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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 K872294
Device Name COMBINATION NITE DRAINAGE UNIT
Applicant
Arnold Technologies
P.O. Box 1211
Leesburg,  FL  32749
Applicant Contact JAN ARNOLD
Correspondent
Arnold Technologies
P.O. Box 1211
Leesburg,  FL  32749
Correspondent Contact JAN ARNOLD
Regulation Number876.5900
Classification Product Code
EXB  
Date Received06/16/1987
Decision Date 12/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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