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510(k) K982939

BTF THIN FILM WOUND DRESSING by Bioderm, Inc. — Product Code MGP

K982939 is an FDA 510(k) premarket notification submitted by Bioderm, Inc. for the device "BTF THIN FILM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on October 13, 1998. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Bioderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1998
Date Received
August 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
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)
  • 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)
  • K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING (June 21, 1995)
  • 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 MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)

FDA data resources