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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 St.,
Bldg.#9
Lawerence,  MA  01843
Applicant Contact JASON SWIFT
Correspondent
Obp Corporation
360 Merrimack St.,
Bldg.#9
Lawerence,  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
Predetermined Change
Control Plan Authorized		 No
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