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510(k) K012995

COLLATEK SHEET by Biocore Medical Technologies, Inc. — Product Code MGP

K012995 is an FDA 510(k) premarket notification submitted by Biocore Medical Technologies, Inc. for the device "COLLATEK SHEET". The FDA issued a decision of Substantially Equivalent on October 25, 2001. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Biocore Medical Technologies, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2001
Date Received
September 6, 2001
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 Biocore Medical Technologies, Inc.

  • K022995 — COLLATEK HYDROGEL (December 2, 2002)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K012990 — COLLATEK POWDER (October 24, 2001)

Other clearances for product code MGP

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

FDA data resources