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510(k) K863664

OPHTHALMIC SURGICAL SPECULUM by Myocure, Inc. — Product Code HNC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
September 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Myocure, Inc.

  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K880346 — CANNULAS (May 3, 1988)
  • K880347 — ANESTHESIA/RETROBULBAR NEEDLES (May 3, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K863666 — THE SAVER KIT (October 20, 1986)
  • K863662 — OPHTHALMIC SURGICAL DRAPE (October 20, 1986)

Other clearances for product code HNC

  • K022836 — STEPHENS DISPOSABLE SPECULUM (November 1, 2002)
  • K981235 — OCULOSTAT (July 15, 1998)
  • K964289 — EYE FIXATION SPECULUM (December 17, 1996)
  • K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (October 31, 1986)
  • K843196 — VISITEC EYE SPECULUM (October 5, 1984)
  • K830430 — EYELID SPECULUM (June 10, 1983)
  • K801969 — ASNIS GUIDED SCREW SYSTEMS (August 27, 1980)
  • K760848 — FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (November 2, 1976)
  • K760847 — FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (November 2, 1976)
  • K760849 — FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (November 2, 1976)