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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K994327
Device Name EMBRYON TRANSFER CATHETERS/SETS
Applicant
Rocket Medical Plc
Tyne & Wear
Washington,  GB NE37 1NE
Applicant Contact LES TODD
Correspondent
Rocket Medical Plc
Tyne & Wear
Washington,  GB NE37 1NE
Correspondent Contact LES TODD
Regulation Number884.6110
Classification Product Code
MQF  
Date Received12/22/1999
Decision Date 02/28/2000
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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