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510(k) K903545

CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS by J.J. Skinner, Inc. — Product Code FOZ

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 13, 1990
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by J.J. Skinner, Inc.

  • K961227 — JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY (June 10, 1996)
  • K961683 — JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY (May 10, 1996)
  • K925469 — JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (May 3, 1995)
  • K925467 — JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT (May 11, 1994)
  • K925468 — JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (April 11, 1994)
  • K903544 — CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS (August 31, 1990)

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