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510(k) K083721

MODIFICATION TO ZENIEVA by River'S Edge Pharmaceuticals, LLC — Product Code NAE

K083721 is an FDA 510(k) premarket notification submitted by River'S Edge Pharmaceuticals, LLC for the device "MODIFICATION TO ZENIEVA". The FDA issued a decision of Substantially Equivalent on January 8, 2009. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2009
Date Received
December 15, 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 for product code NAE

  • K082865 — MODIFICATION TO ZENIEVA (October 23, 2008)
  • 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