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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name collector, ostomy
510(k) Number K880306
Device Name EMERGENCY-CLEAN UP(TM) ECP
Applicant
CDC PRODUCTS CORP.
23-23 BORDEN AVE.
LONG ISLAND CITY,  NY  11101
Applicant Contact JAYNE DROBBIN
Correspondent
CDC PRODUCTS CORP.
23-23 BORDEN AVE.
LONG ISLAND CITY,  NY  11101
Correspondent Contact JAYNE DROBBIN
Regulation Number876.5900
Classification Product Code
EXB  
Date Received01/25/1988
Decision Date 05/20/1988
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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