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510(k) K833688

SUTURE REMOVAL KITS STERILE by Carwild Corp. — Product Code KGX

K833688 is an FDA 510(k) premarket notification submitted by Carwild Corp. for the device "SUTURE REMOVAL KITS STERILE". The FDA issued a decision of Substantially Equivalent on May 31, 1984. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Carwild Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1984
Date Received
October 31, 1983
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 Carwild Corp.

  • K913303 — LAP SPONGES, MODIFIED (August 6, 1992)
  • K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (July 23, 1992)
  • K791872 — LAP SPONGES (November 13, 1979)
  • K791871 — NEUROLOGICAL SPONGES (PATTIES) (November 5, 1979)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)

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