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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laryngoscope, endoscope
510(k) Number K914120
Device Name SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
Applicant
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Applicant Contact WILLIAM W ABRAHAM
Correspondent
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number876.1500
Classification Product Code
GCI  
Date Received09/13/1991
Decision Date 10/30/1991
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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