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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enema Kit
510(k) Number K872992
Device Name SPS SUSPENSION ENEMA KIT
Applicant
Carolina Medical Products Co.
C/O Burditt, Bowles & Radzius
1029 Vermont Ave. NW, Suite 200
Washington,  DC  20005
Applicant Contact DONALD R STONE
Correspondent
Carolina Medical Products Co.
C/O Burditt, Bowles & Radzius
1029 Vermont Ave. NW, Suite 200
Washington,  DC  20005
Correspondent Contact DONALD R STONE
Regulation Number876.5210
Classification Product Code
FCE  
Date Received07/31/1987
Decision Date 09/17/1987
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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