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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K091838
Device Name OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
Applicant
OBP MEDICAL
360 MERRIMACK STREET,
BUILDING#9
LAWERENCE,  MA  01843
Applicant Contact KEITH LARSON
Correspondent
OBP MEDICAL
360 MERRIMACK STREET,
BUILDING#9
LAWERENCE,  MA  01843
Correspondent Contact KEITH LARSON
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Codes
HET   ODC  
Date Received06/22/2009
Decision Date 12/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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