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510(k) K905463

GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION by Angiosystems, Inc. — Product Code FOZ

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 22, 1991
Date Received
December 5, 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 Angiosystems, Inc.

  • K905464 — MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING (May 31, 1991)
  • K905459 — SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM (April 5, 1991)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)
  • K905465 — STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE (February 11, 1991)
  • K905466 — STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE (February 11, 1991)
  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)
  • K864688 — ARNOLD-KING PRESSURE DRESSING (January 12, 1987)
  • K843259 — ANGIO SYS FLUOROSCOPE DRAPE (September 21, 1984)
  • K843258 — ANGIO SYS BRACHIAL ANGIO DRAPE (September 21, 1984)

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