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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 K942516
Device Name 10-0 CASSETTE
Applicant
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Applicant Contact DON HAAR
Correspondent
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Correspondent Contact DON HAAR
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/26/1994
Decision Date 07/25/1994
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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