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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Falloposcope
510(k) Number K962587
Device Name CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
Applicant
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Applicant Contact NANCY NADDAFF
Correspondent
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Correspondent Contact NANCY NADDAFF
Regulation Number884.1690
Classification Product Code
MKO  
Date Received07/01/1996
Decision Date 01/31/1997
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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