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510(k) K953399

NEEDLE OR CUTTER by Biophysic Medical, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
July 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Biophysic Medical, Inc.

  • K893035 — OPHTHASCAN 'S' MINI-A (June 12, 1989)
  • K890509 — INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM (March 24, 1989)
  • K884595 — OPHTHASCAN MINI-B (January 3, 1989)
  • K884456 — STERILE DISPOSABLE ENDOCULAR PROBE (December 9, 1988)
  • K883719 — INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (October 18, 1988)
  • K881494 — FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER (August 30, 1988)
  • K881459 — NANOLAS ND:YAG OPHTHALMIC LASER (April 13, 1988)
  • K873460 — OPHTHALAS DYE OPHTHALMIC LASER (October 29, 1987)
  • K853116 — PAXIAL (October 31, 1985)
  • K844686 — OPHTHASCAN B (September 13, 1985)

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