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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectacle, Operating (Loupe), Ophthalmic
510(k) Number K934494
Device Name SURGITEL
Applicant
General Scientific Corp.
77 Enterprise Dr.
Ann Arbor,  MI  48103
Applicant Contact HARVEY C BAUSS
Correspondent
General Scientific Corp.
77 Enterprise Dr.
Ann Arbor,  MI  48103
Correspondent Contact HARVEY C BAUSS
Regulation Number886.4770
Classification Product Code
HOH  
Date Received09/15/1993
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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