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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 K960217
Device Name CPR URINE BAG
Applicant
CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO,  FL  32811
Applicant Contact RICHARD L ELLWOOD
Correspondent
CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO,  FL  32811
Correspondent Contact RICHARD L ELLWOOD
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received01/16/1996
Decision Date 03/28/1996
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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