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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 K871628
Device Name PALEX (R) OSTOMY
Applicant
Industrias Palex C/O Dma Med-Chem Corp.
60 Cutter Mill Rd.
Suite 514
Great Neck,  NY  11021
Applicant Contact LEO R MINDICK
Correspondent
Industrias Palex C/O Dma Med-Chem Corp.
60 Cutter Mill Rd.
Suite 514
Great Neck,  NY  11021
Correspondent Contact LEO R MINDICK
Regulation Number876.5900
Classification Product Code
EXB  
Date Received04/27/1987
Decision Date 07/08/1987
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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