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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Accessories, Cleaning Brushes, For Endoscope
510(k) Number K874239
Device Name CLEANING BRUSH
Applicant
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Applicant Contact SUSAN P BJORKMAN
Correspondent
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Correspondent Contact SUSAN P BJORKMAN
Regulation Number876.1500
Classification Product Code
MNL  
Date Received10/16/1987
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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