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510(k) K844112

MYOPACH ULTRASONIC PACHOMETER by Myocure, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1986
Date Received
October 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
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)
  • K863666 — THE SAVER KIT (October 20, 1986)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K863662 — OPHTHALMIC SURGICAL DRAPE (October 20, 1986)

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