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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 K914997
Device Name ASP-IRRATOR
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501
Applicant Contact MARTIN P FORTE
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501
Correspondent Contact MARTIN P FORTE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/07/1991
Decision Date 01/07/1992
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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