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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 K913620
Device Name ENEMA KIT
Applicant
York County Blind Center
1380 Spahn Ave.
York,  PA  17403
Applicant Contact WILLLIAM RHINESMITH
Correspondent
York County Blind Center
1380 Spahn Ave.
York,  PA  17403
Correspondent Contact WILLLIAM RHINESMITH
Regulation Number876.5210
Classification Product Code
FCE  
Date Received08/13/1991
Decision Date 11/01/1991
Decision Substantially Equivalent - Kit (SESK)
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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