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510(k) K863663

OPHTHALMIC SURGICAL OCULAR MARKERS by Myocure, Inc. — Product Code HMR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1986
Date Received
September 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Ocular
Device Class
Class I
Regulation Number
886.4570
Review Panel
OP
Submission Type

Other clearances by Myocure, Inc.

  • K880347 — ANESTHESIA/RETROBULBAR NEEDLES (May 3, 1988)
  • K880346 — CANNULAS (May 3, 1988)
  • K880345 — CYSTOTOMES/KNIFES (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)
  • K863666 — THE SAVER KIT (October 20, 1986)
  • K863662 — OPHTHALMIC SURGICAL DRAPE (October 20, 1986)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)

Other clearances for product code HMR

  • K053475 — OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (March 3, 2006)
  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)
  • K872747 — LASER CENTERING DEVICE (September 4, 1987)
  • K861535 — OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU (May 14, 1986)