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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bag, urine collection, leg, for external use, sterile
510(k) Number K945204
Device Name URINE COLLECTOR & ACCESSORIES
Applicant
NELMED CORP.
35 HAWTHORNE ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ERIK NELSON
Correspondent
NELMED CORP.
35 HAWTHORNE ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ERIK NELSON
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received10/25/1994
Decision Date 11/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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