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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name anoscope and accessories
510(k) Number K121604
Device Name ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
Applicant
OBP CORPORATION
360 merrimack street
building 9
lawrence,  MA  01843
Applicant Contact jason swift
Correspondent
OBP CORPORATION
360 merrimack street
building 9
lawrence,  MA  01843
Correspondent Contact jason swift
Regulation Number876.1500
Classification Product Code
FER  
Date Received06/01/2012
Decision Date 07/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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