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510(k) K991061

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING by Dermaphylyx, Inc. — Product Code NAE

K991061 is an FDA 510(k) premarket notification submitted by Dermaphylyx, Inc. for the device "DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on June 28, 1999. 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. Dermaphylyx, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1999
Date Received
March 30, 1999
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 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)
  • 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 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)
  • 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