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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K942897
Device Name OPTHALMIC WIPE
Applicant
Surgin Surgical Instrumentation, Inc.
14762 Bentley Cir.
Tustin,  CA  92680
Applicant Contact DON W HAAR
Correspondent
Surgin Surgical Instrumentation, Inc.
14762 Bentley Cir.
Tustin,  CA  92680
Correspondent Contact DON W HAAR
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/20/1994
Decision Date 08/05/1994
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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