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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K943070
Device Name REUSABLE PROBES
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 Number876.1500
Classification Product Code
GCJ  
Date Received06/28/1994
Decision Date 07/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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