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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K950600
Device Name VACUUM SURGE SUPRESSER
Applicant
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Applicant Contact DON W HAAR
Correspondent
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Correspondent Contact DON W HAAR
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/09/1995
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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