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510(k) K951166

BIODERM MEDICAL HYDROGEL ISLAND DRESSING by Bioderm, Inc. — Product Code NAE

K951166 is an FDA 510(k) premarket notification submitted by Bioderm, Inc. for the device "BIODERM MEDICAL HYDROGEL ISLAND DRESSING". The FDA issued a decision of Substantially Equivalent on June 21, 1995. 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. Bioderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
March 14, 1995
Clearance Type
Traditional
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 Bioderm, Inc.

  • K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING (May 18, 1999)
  • K982778 — BIODERM FOAM WOUND DRESSING (October 21, 1998)
  • K982939 — BTF THIN FILM WOUND DRESSING (October 13, 1998)
  • K980451 — BIODERM CALCIUM ALGINATE DRESSING (April 9, 1998)
  • K973429 — BIODERM FOAM WOUND DRESSING (December 1, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K963602 — BIODERM PVP FOAM WOUND DRESSING (October 30, 1996)
  • K951842 — BIODERM MEDICAL TRANSPARENT FILM DRESSING (June 12, 1995)
  • K950685 — BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING (June 9, 1995)
  • K950619 — BIODERM MEDICAL FOAM WOUND DRESSING (April 25, 1995)

Other clearances for product code NAE

  • K083721 — MODIFICATION TO ZENIEVA (January 8, 2009)
  • 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)
  • K950412 — CURAGEL HYDROGEL WOUND DRESSING (March 24, 1995)

FDA data resources