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510(k) K842983

AMPCO OPTHALMIC TRAY by Associated Medical Products Co. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1985
Date Received
July 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Associated Medical Products Co.

  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K932216 — C-SECTION, LABOR & DELIVERY TRAYS (PACKS) (April 19, 1994)
  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K932217 — MAJOR, MINOR, BASIN TRAYS (PACKS) (November 15, 1993)
  • K932220 — LAP CHOLY TRAYS (PACKS) (September 27, 1993)
  • K932218 — CARDIAC CATH OR ANGIOGRAPHIC TRAYS (August 27, 1993)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K843114 — AMPCO PROCEDURE TRAYS / PACKS (August 8, 1984)
  • K823839 — AMPCO KIDNEY DIALYSIS TRAY (March 29, 1983)
  • K821579 — SKIN SCRUB-TRAY (July 21, 1982)

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  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (June 26, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)