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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 K914098
Device Name LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR
Applicant
SURGICAL INNOVATIONS CORP.
2545 CHICAGO AVE.
SUITE 600
MINNEAPOLIS,  MN  55404
Applicant Contact J PIETRAFITTA
Correspondent
SURGICAL INNOVATIONS CORP.
2545 CHICAGO AVE.
SUITE 600
MINNEAPOLIS,  MN  55404
Correspondent Contact J PIETRAFITTA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/12/1991
Decision Date 10/28/1991
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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