510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NACClass I

Dressing, Wound, Hydrophilic

21 CFR 878.4018 / General, Plastic Surgery
FDA source (opens on fda.gov)

NAC is the FDA product code for Dressing, Wound, Hydrophilic, a class I device type, regulated under 21 CFR 878.4018. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
NAC
Device name
Dressing, Wound, Hydrophilic
Regulation
21 CFR 878.4018
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
9

Clearances, product code NAC

By decision year
4 clearances under product code NAC with a decision year between 1991 and 2008, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NAC by decision year
YearClearances
19912
19931
20081

Applicants with the most clearances

Product code NAC
Applicants holding the most 510(k) clearances under product code NAC
ApplicantClearances
Adri/Technam1
Avitar, Inc.1
Dow B. Hickam, Inc.1
Scivolutions, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 467 companies shown, in name order