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510(k) K974890

ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 by Acutek Adhesive Specialties, Inc. — Product Code MGP

K974890 is an FDA 510(k) premarket notification submitted by Acutek Adhesive Specialties, Inc. for the device "ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002". 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. Acutek Adhesive Specialties, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1998
Date Received
December 30, 1997
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 Acutek Adhesive Specialties, Inc.

  • K974891 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 (October 21, 1998)
  • K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 (October 13, 1998)
  • K962698 — ACUTEK'S CLEARPASAGE (September 9, 1996)
  • K951644 — ACUTEK'S CLEARPASSAGE (July 3, 1995)
  • K943111 — TRANSPARENT DRESSING (September 12, 1994)

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