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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 K932604
Device Name UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC
Applicant
UNISURGE, INC.
10231 BUBB RD.
CUPERTINO,  CA  95014
Applicant Contact DONALD V JOHNSON
Correspondent
UNISURGE, INC.
10231 BUBB RD.
CUPERTINO,  CA  95014
Correspondent Contact DONALD V JOHNSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/28/1993
Decision Date 08/10/1993
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
Predetermined Change
Control Plan Authorized		 No
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