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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 K921336
Device Name TROCAR GRASPER/ANVIL APPROXIMATOR
Applicant
ENDOSCOPIC SURGICAL PRODUCTS, INC.
5571 BRISTOL LN.
MINNETONKA,  MN  55343
Applicant Contact JOSEPH PIETRAFITTA
Correspondent
ENDOSCOPIC SURGICAL PRODUCTS, INC.
5571 BRISTOL LN.
MINNETONKA,  MN  55343
Correspondent Contact JOSEPH PIETRAFITTA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/18/1992
Decision Date 11/06/1992
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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