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510(k) K992302

DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS by Dermaphylyx, Inc. — Product Code MGP

K992302 is an FDA 510(k) premarket notification submitted by Dermaphylyx, Inc. for the device "DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS". The FDA issued a decision of Substantially Equivalent on September 14, 1999. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Dermaphylyx, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1999
Date Received
July 8, 1999
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 Dermaphylyx, Inc.

  • K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING (August 12, 1999)
  • K991933 — DERMAPHYLYX FOAM ISLAND DRESSING (July 30, 1999)
  • K991608 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (July 20, 1999)
  • K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING (July 20, 1999)
  • K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (June 28, 1999)
  • K990891 — DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING (May 27, 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)

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)
  • 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)
  • K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSING (December 9, 1998)

FDA data resources