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510(k) K082865

MODIFICATION TO ZENIEVA by Gorbec Pharmaceutical Services, Inc. — Product Code NAE

K082865 is an FDA 510(k) premarket notification submitted by Gorbec Pharmaceutical Services, Inc. for the device "MODIFICATION TO ZENIEVA". The FDA issued a decision of Substantially Equivalent on October 23, 2008. The device falls under product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic), a Class I device regulated under 21 CFR 878.4022. Gorbec Pharmaceutical Services, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2008
Date Received
September 29, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Device Class
Class I
Regulation Number
878.4022
Review Panel
SU
Submission Type

Other clearances by Gorbec Pharmaceutical Services, Inc.

  • K100839 — BARIREP (May 11, 2010)
  • K073246 — ZENIEVA (July 23, 2008)

Other clearances for product code NAE

  • K083721 — MODIFICATION TO ZENIEVA (January 8, 2009)
  • K073246 — ZENIEVA (July 23, 2008)
  • K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING (September 17, 1999)
  • K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (June 28, 1999)
  • K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (August 21, 1997)
  • K971597 — COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (July 29, 1997)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K952945 — AQUAFLO HYDROGEL WOUND DRESSING & PACKER (August 23, 1995)
  • K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING (June 21, 1995)
  • K950412 — CURAGEL HYDROGEL WOUND DRESSING (March 24, 1995)

FDA data resources