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510(k) K952581

GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR by Gamp & Assoc. — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1996
Date Received
June 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

Other clearances by Gamp & Assoc.

  • K952585 — GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (January 5, 1996)
  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954306 — GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR 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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