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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Ac-Powered
510(k) Number K971538
Device Name MENTOR GEMINI HEMOSTATIC ERASER
Applicant
Mentor Ophthalmics, Inc.
3000 Longwater Dr.
Norwell,  MA  02061
Applicant Contact DAVID M DOWNEY
Correspondent
Mentor Ophthalmics, Inc.
3000 Longwater Dr.
Norwell,  MA  02061
Correspondent Contact DAVID M DOWNEY
Regulation Number886.4115
Classification Product Code
HQO  
Date Received04/28/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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