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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 K972210
Device Name RESECTOSCOPE SAFETY SHEATH
Applicant
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Applicant Contact CINDY DOMECUS
Correspondent
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Correspondent Contact CINDY DOMECUS
Regulation Number884.1690
Classification Product Code
HIH  
Date Received06/11/1997
Decision Date 09/05/1997
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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