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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 K930607
Device Name GRIPPER
Applicant
SURGICAL INSTRUMENT, INC.
1030 RICHFIELD RD.
PLACENTIA,  CA  92670
Applicant Contact DON W HAAR
Correspondent
SURGICAL INSTRUMENT, INC.
1030 RICHFIELD RD.
PLACENTIA,  CA  92670
Correspondent Contact DON W HAAR
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/05/1993
Decision Date 02/15/1994
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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