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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K941494
Device Name ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS
Applicant
SHARPE ENDOSURGICAL CORP.
1839 BUERKLE RD.
ST. PAUL,  MN  55110
Applicant Contact W. TIM MILLER
Correspondent
SHARPE ENDOSURGICAL CORP.
1839 BUERKLE RD.
ST. PAUL,  MN  55110
Correspondent Contact W. TIM MILLER
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/28/1994
Decision Date 04/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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