Home / 510(k) Clearances / K894274

510(k) K894274

EXUSORB TRANSPARENT DRESSING by Controlled Therapeutics Corp. — Product Code KGX

K894274 is an FDA 510(k) premarket notification submitted by Controlled Therapeutics Corp. for the device "EXUSORB TRANSPARENT DRESSING". The FDA issued a decision of Substantially Equivalent on August 18, 1989. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Controlled Therapeutics Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1989
Date Received
June 22, 1989
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 Controlled Therapeutics Corp.

  • K896176 — EXUSORB(TM) DRY/WET DRESSING (November 24, 1989)
  • K895606 — EXUSORB(TM) GEL DRESSING (October 19, 1989)
  • K894996 — EXUSORB(TM) GRANULES (September 28, 1989)

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)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources