Home / 510(k) Clearances / K932422

510(k) K932422

3M TEGADERM HP TRANSPARENT DRESSING by 3M Health Care, Ltd. — Product Code KGX

K932422 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "3M TEGADERM HP TRANSPARENT DRESSING". The FDA issued a decision of Substantially Equivalent on December 27, 1993. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1993
Date Received
May 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by 3M Health Care, Ltd.

  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (March 31, 1995)
  • K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (March 6, 1995)
  • K941748 — STERI-VAC GAS STERILIZER MODEL 8XL (December 2, 1994)
  • K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX (February 10, 1994)
  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933005 — AVI MODEL 600 SYRINGE PUMP (October 25, 1993)
  • K933006 — AVI INFUSION PUMPS, ADDITIONAL INTENDED USE (October 25, 1993)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources