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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light source, endoscope, xenon arc
510(k) Number K932281
Device Name VERRES NEEDLE
Applicant
SURGEON SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Applicant Contact DON W HAAR
Correspondent
SURGEON SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN,  CA  92680
Correspondent Contact DON W HAAR
Regulation Number876.1500
Classification Product Code
GCT  
Date Received05/12/1993
Decision Date 08/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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