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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 K914967
Device Name SHARP ENDOKNOT PUSHER
Applicant
Sharpe Endosurgical Corp.
C/O Paladin Medical,Inc.
P.O.Box 560
Still Water,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
Sharpe Endosurgical Corp.
C/O Paladin Medical,Inc.
P.O.Box 560
Still Water,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/05/1991
Decision Date 11/22/1991
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
Predetermined Change
Control Plan Authorized		 No
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