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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
Contact jason swift
Regulation Number876.1500
Classification Product Code
FER  
Date Received06/01/2012
Decision Date 07/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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