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

Decontamination Kit

21 CFR 878.4014 / General, Plastic Surgery
FDA source (opens on fda.gov)

MAC is the FDA product code for Decontamination Kit, a class I device type, regulated under 21 CFR 878.4014. 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MAC
Device name
Decontamination 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code MAC

By decision year
2 clearances under product code MAC with a decision year between 1989 and 2003, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MAC by decision year
YearClearances
19891
20031

Applicants with the most clearances

Product code MAC
Applicants holding the most 510(k) clearances under product code MAC
ApplicantClearances
Dept. of the Army2

Companies listing this code with FDA

Companies whose registered establishments list this code