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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 K951946
Device Name HYSTEROSYS FLEXIBLE HYSTEROCOPE
Applicant
Ovamed Corp.
760 San Aleso Ave.
Sunnyvale,  CA  94086
Applicant Contact CHRISTINE DECARIA
Correspondent
Ovamed Corp.
760 San Aleso Ave.
Sunnyvale,  CA  94086
Correspondent Contact CHRISTINE DECARIA
Regulation Number884.1690
Classification Product Code
HIH  
Date Received04/26/1995
Decision Date 11/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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