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510(k) K890622

SURG-E-TROL SYSTEM I AND SYSTEM II by Mentor O & O, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1989
Date Received
February 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Mentor O & O, Inc.

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  • K912904 — MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (June 11, 1992)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K910637 — MENTOR(R) SUR-E-TROL(R) (May 13, 1991)
  • K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (May 2, 1991)
  • K903878 — MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (November 5, 1990)
  • K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (September 11, 1989)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)
  • K881001 — MENTOR WET-FIELD*II COAGULATOR (May 13, 1988)

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