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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 K101733
Device Name REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
Applicant
Sac, LLC Dba Pinnacle Medical Surgical
P.O. Box 782108
Orlando,  FL  32878
Applicant Contact DAVE STRAIN
Correspondent
Sac, LLC Dba Pinnacle Medical Surgical
P.O. Box 782108
Orlando,  FL  32878
Correspondent Contact DAVE STRAIN
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
GEI   HET   HIF   KKX  
Date Received06/21/2010
Decision Date 06/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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