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NAE — Dressing, Wound, Hydrogel Without Drug And/Or Biologic Class I

FDA Device Classification

Classification Details

Product Code
NAE
Device Class
Class I
Regulation Number
878.4022
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K083721river edge pharmaceuticalsMODIFICATION TO ZENIEVAJanuary 8, 2009
K082865gorbec pharmaceutical servicesMODIFICATION TO ZENIEVAOctober 23, 2008
K073246gorbec pharmaceutical servicesZENIEVAJuly 23, 2008
K992094giltech plusGILTECH PLUS HYDROGEL SKIN DRESSINGSeptember 17, 1999
K991061dermaphylyxDERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGJune 28, 1999
K972646ludlow technical productsAD-HEAL HYDROGEL DRESSING, VARIOUS SIZESAugust 21, 1997
K971597coloplastCOMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)July 29, 1997
K962352north american sterilization and packagingHYDROGEL SKIN DRESSINGAugust 2, 1996
K952945sherwood medicalAQUAFLO HYDROGEL WOUND DRESSING & PACKERAugust 23, 1995
K951166biodermBIODERM MEDICAL HYDROGEL ISLAND DRESSINGJune 21, 1995
K950412kendall healthcare products co. div.of tyco healthCURAGEL HYDROGEL WOUND DRESSINGMarch 24, 1995
K945832brady medical productsBRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGSMarch 1, 1995
K942748smith and nephew unitedINTRASITEJune 29, 1994
K941019brady medical productsBRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSINGMay 4, 1994
K935848brady medical productsBRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSINGFebruary 15, 1994
K935705smith and nephew unitedALLEVYN ISLAND WOUND DRESSINGFebruary 15, 1994
K934601ndm acquisitionNDM HYDROGAUZE WOUND DRESSINGFebruary 15, 1994
K932336johnson and johnson medicalNU-GEL ISLAND WOUND DRESSINGFebruary 9, 1994
K931618convatec, a division of e.r. squibb and sonsDUODERM HYDROCOLLOID GELDecember 10, 1993
K926508smith and nephew unitedINTRASITE GELJuly 13, 1993