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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 K032093
Device Name PARIEFIX
Applicant
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GDW  
Date Received07/07/2003
Decision Date 10/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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