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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 St.,
Bldg.#9
Lawerence,  MA  01843
Applicant Contact KEITH LARSON
Correspondent
Obp Medical
360 Merrimack St.,
Bldg.#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
Predetermined Change
Control Plan Authorized		 No
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