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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sound, Uterine
510(k) Number K935665
Device Name INTRAUTERINE SOUND
Applicant
Rocket of London, Ltd.
Wear Industrial Estate
Washington
Tyne & Wear,  GB NE37 1NE
Applicant Contact L. TODD
Correspondent
Rocket of London, Ltd.
Wear Industrial Estate
Washington
Tyne & Wear,  GB NE37 1NE
Correspondent Contact L. TODD
Regulation Number884.4530
Classification Product Code
HHM  
Date Received11/26/1993
Decision Date 02/24/1994
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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