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510(k) K954306

GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE by Gamp & Assoc. — Product Code HQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1995
Date Received
September 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

Other clearances by Gamp & Assoc.

  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K952585 — GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (January 5, 1996)
  • K952581 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR (January 5, 1996)
  • K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (December 22, 1995)
  • K952584 — GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK (September 1, 1995)
  • K952580 — GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (September 1, 1995)
  • K952586 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (September 1, 1995)

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