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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name speculum, vaginal, nonmetal
510(k) Number K091937
Device Name OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
Applicant
OBP CORPORATION
360 MERRIMACK STREET
BUILDING 9
LAWRENCE,  MA  01843
Applicant Contact KEITH ISAACSON
Correspondent
OBP CORPORATION
360 MERRIMACK STREET
BUILDING 9
LAWRENCE,  MA  01843
Correspondent Contact KEITH ISAACSON
Regulation Number884.4530
Classification Product Code
HIB  
Date Received06/30/2009
Decision Date 09/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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