Home / 510(k) Clearances / K973036

510(k) K973036

3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES by 3M Healthcare — Product Code MGP

K973036 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES". The FDA issued a decision of SN on Nov 12, 1997. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. 3M Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
Nov 12, 1997
Date Received
Aug 14, 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

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  • K153571 — Cavilon Advanced High Endurance Skin Protectant (Aug 23, 2016)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (Aug 18, 2014)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (Jul 25, 2014)
  • K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (Jul 26, 1998)
  • K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (May 15, 1998)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (Oct 25, 2001)
  • K012997 — COLLATEK FOAM (Oct 25, 2001)
  • K001508 — LASERSKIN DRESSING (Jul 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (Dec 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (Oct 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (Sep 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (Sep 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 (Mar 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (Mar 3, 1999)

FDA data resources