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510(k) K844463

DERMIDRESS by Kells Medical, Inc. — Product Code KGX

K844463 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "DERMIDRESS". The FDA issued a decision of Substantially Equivalent on January 8, 1985. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1985
Date Received
November 20, 1984
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 Kells Medical, Inc.

  • K926333 — CPR PLUS (November 8, 1993)
  • K890093 — PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET (July 24, 1989)
  • K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
  • K890095 — PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
  • K861972 — DERMISTRIP (June 27, 1986)
  • K844072 — DERMIZIP SKIN CLOSURE DEVICE (November 5, 1984)
  • K832678 — PHONATORY FUNCTION ANALYZER PS-77 (March 7, 1984)
  • K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)
  • K823118 — SAY (January 7, 1983)
  • K823226 — SN-100 DOCTOR'S ROUND (November 22, 1982)

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