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510(k) K990891

DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING by Dermaphylyx, Inc. — Product Code FRO

Clearance Details

Decision
SN ()
Decision Date
May 27, 1999
Date Received
March 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Dermaphylyx, Inc.

  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING (August 12, 1999)
  • K991933 — DERMAPHYLYX FOAM ISLAND DRESSING (July 30, 1999)
  • K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING (July 20, 1999)
  • K991608 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (July 20, 1999)
  • K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (June 28, 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)

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