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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 K945394
Device Name INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
Applicant
INNOVATIVE SURGICAL, INC.
3071 CONTINENTAL DR.,
SUITE 102
WEST PALM BEACH,  FL  33407
Applicant Contact MARK C HAMBLIN
Correspondent
INNOVATIVE SURGICAL, INC.
3071 CONTINENTAL DR.,
SUITE 102
WEST PALM BEACH,  FL  33407
Correspondent Contact MARK C HAMBLIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/03/1994
Decision Date 01/27/1995
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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