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

Skin Prep Tray

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

OJU is the FDA product code for Skin Prep Tray, a class I device type, regulated under 21 CFR 878.4800. 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 one 510(k) clearance under this code, the most recent dated , and 21 recalls.

Classification record

Product code
OJU
Device name
Skin Prep Tray
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 878.4800
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
1
Ingested recalls
21

Clearances, product code OJU

By decision year
1 clearance under product code OJU with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OJU by decision year
YearClearances
19781

Applicants with the most clearances

Product code OJU
Applicants holding the most 510(k) clearances under product code OJU
ApplicantClearances
Pharmaseal Div., Baxter Healthcare Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order