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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 K140938
Device Name OSTOM-I ALERT
Applicant
11 HEALTH AND TECHNOLOGIES LLC
1468 Harwell Avenue
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
11 HEALTH AND TECHNOLOGIES LLC
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number876.5900
Classification Product Code
EXB  
Subsequent Product Codes
EZQ   EZS  
Date Received04/11/2014
Decision Date 10/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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