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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Salpingography
510(k) Number K931534
Device Name OVAMED INTRAUTERINE ACCESS CATHETER
Applicant
Ovamed Corp.
111 W. Evelyn Ave.,
Suite 214
Sunnyvale,  CA  94086
Applicant Contact CHRISTINE DECARIA
Correspondent
Ovamed Corp.
111 W. Evelyn Ave.,
Suite 214
Sunnyvale,  CA  94086
Correspondent Contact CHRISTINE DECARIA
Regulation Number884.4530
Classification Product Code
MOV  
Date Received03/29/1993
Decision Date 07/28/1995
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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