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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 K000656
Device Name EMBRYON GIFT TRANSFER CATHETERS/SETS
Applicant
ROCKET MEDICAL PLC
WARE INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR,  GB NE37 1NE
Applicant Contact LES TODD
Correspondent
ROCKET MEDICAL PLC
WARE INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR,  GB NE37 1NE
Correspondent Contact LES TODD
Regulation Number884.6110
Classification Product Code
MQF  
Date Received02/28/2000
Decision Date 03/09/2000
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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