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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, feeding
510(k) Number K884415
Device Name EP-100 (SERIES)
Applicant
STEREOTACTIC MEDICAL SYSTEMS, INC.
2801 SO. 1935 WEST
WEST VALLEY CITY,  UT  84119
Applicant Contact GLEN S PUTNAM
Correspondent
STEREOTACTIC MEDICAL SYSTEMS, INC.
2801 SO. 1935 WEST
WEST VALLEY CITY,  UT  84119
Correspondent Contact GLEN S PUTNAM
Regulation Number876.5980
Classification Product Code
FPD  
Date Received10/20/1988
Decision Date 02/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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