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510(k) K926470

LASER AND EMPHASIS SCLEROSTOMY TIP by Summit Technology, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
December 28, 1992
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 Summit Technology, Inc.

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  • K912522 — OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER (July 25, 1991)
  • K904470 — SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (December 24, 1990)

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