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510(k) K863662

OPHTHALMIC SURGICAL DRAPE by Myocure, Inc.

K863662 is an FDA 510(k) premarket notification submitted by Myocure, Inc. for the device "OPHTHALMIC SURGICAL DRAPE". The FDA issued a decision of Substantially Equivalent on October 20, 1986. Myocure, Inc. has at least 10 other 510(k) clearances on record.

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

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)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)

FDA data resources