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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Anesthesia, Paracervical
510(k) Number K052365
Device Name CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
Applicant
Rocket Medical Plc
Wear Industrial Estate
Washington
Tyne & Wear,  GB NE38 9BZ
Applicant Contact TRACY CHARLTON
Correspondent
Rocket Medical Plc
Wear Industrial Estate
Washington
Tyne & Wear,  GB NE38 9BZ
Correspondent Contact TRACY CHARLTON
Regulation Number884.5100
Classification Product Code
HEE  
Date Received08/29/2005
Decision Date 10/17/2005
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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