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510(k) K852055

ASCON OPHTHALMIC SPONGE by Ascon Medical Instruments, Ltd. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1985
Date Received
May 9, 1985
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 Ascon Medical Instruments, Ltd.

  • K852054 — CONTACT LENS LOUPE, INSPETION LOUPE (September 5, 1985)
  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852057 — ASCON SURGICAL INSTRUMENTS (June 27, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)

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  • 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)