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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K000394
Device Name CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
Applicant
Rocket Medical Plc
Wear Ind. Estate District 6
Washington, Tyne & Wear,  GB NE37 1NE
Applicant Contact LES TODD
Correspondent
Rocket Medical Plc
Wear Ind. Estate District 6
Washington, Tyne & Wear,  GB NE37 1NE
Correspondent Contact LES TODD
Regulation Number884.6120
Classification Product Code
MQG  
Date Received02/07/2000
Decision Date 02/29/2000
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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