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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K992655
Device Name FERTILOSCOPY KIT FH 1.29/FTO 1.40
Applicant
Soprane S.A.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Soprane S.A.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number884.1640
Classification Product Code
HEW  
Subsequent Product Codes
HET   HIH  
Date Received08/09/1999
Decision Date 03/13/2000
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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