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510(k) K850133

VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. by Consolidated Medical Equipment, Inc. — Product Code KGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1985
Date Received
January 14, 1985
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 Consolidated Medical Equipment, Inc.

  • K854040 — I.V. DRESSING (January 9, 1986)
  • K850132 — DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (April 9, 1985)
  • K850130 — PRN ECG ELECTRODE (April 9, 1985)
  • K850037 — CLOSED WOUND DRAIN (March 19, 1985)
  • K844942 — PLURA-GARD CHEST DRAINAGE SYSTEM (March 12, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (March 5, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (March 5, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (February 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (February 21, 1985)
  • K844371 — HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE (February 20, 1985)

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)