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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 K871738
Device Name OSTO-PURE
Applicant
Clearchem Corp.
2601 Adgate Rd.
P.O. Box 446
Lima,  OH  45805
Applicant Contact ROBERT F HEIL
Correspondent
Clearchem Corp.
2601 Adgate Rd.
P.O. Box 446
Lima,  OH  45805
Correspondent Contact ROBERT F HEIL
Regulation Number876.5900
Classification Product Code
EXB  
Date Received05/05/1987
Decision Date 08/12/1987
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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