510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MLSClass II

Labor And Delivery Kit

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

MLS is the FDA product code for Labor And Delivery Kit, a class II device type, regulated under 21 CFR 884.4530. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 46 recalls.

Classification record

Product code
MLS
Device name
Labor And Delivery Kit
FDA definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
46

Clearances, product code MLS

By decision year
6 clearances under product code MLS with a decision year between 1994 and 1996, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code MLS by decision year
YearClearances
19944
19962

Applicants with the most clearances

Product code MLS
Applicants holding the most 510(k) clearances under product code MLS
ApplicantClearances
Cush Medical Products2
Associated Medical Products Co.1
Carapace, Inc.1
Custom Pack Reliability1
Devon Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order