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510(k) K890509

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM by Biophysic Medical, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1989
Date Received
February 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Other clearances by Biophysic Medical, Inc.

  • K953399 — NEEDLE OR CUTTER (October 30, 1995)
  • K893035 — OPHTHASCAN 'S' MINI-A (June 12, 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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