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510(k) K905460

STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY by Angiosystems, Inc. — Product Code HMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1991
Date Received
December 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Patient, Ophthalmic
Device Class
Class II
Regulation Number
878.4370
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)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)
  • K905463 — GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION (January 22, 1991)
  • K864688 — ARNOLD-KING PRESSURE DRESSING (January 12, 1987)
  • K843258 — ANGIO SYS BRACHIAL ANGIO DRAPE (September 21, 1984)
  • K843257 — ANGIO SYS STERILE FIELD COVER (September 21, 1984)

Other clearances for product code HMT

  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K872620 — SOLOS EYESITE DRAPES (July 31, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K854613 — SURGICAL DRAPES, OPHTHALMIN (February 13, 1986)
  • K831340 — DRAIN-R-DRAPE(EYE (June 8, 1983)
  • K830822 — EYE DRAPE (April 6, 1983)