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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 K913172
Device Name ENDOSCOPIC DELIVERY SYSTEM
Applicant
Medco Products, Co., Inc.
232 W. Cummings Park
Woburn,  MA  01801
Applicant Contact DIANE TIERNAN
Correspondent
Medco Products, Co., Inc.
232 W. Cummings Park
Woburn,  MA  01801
Correspondent Contact DIANE TIERNAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/17/1991
Decision Date 09/06/1991
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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