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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K000340
Device Name HYSTALOG HSG CATHETER
Applicant
ROCKET MEDICAL PLC
WEAR IND. ESTATE DISTRICT 6
WASHINGTON, TYNE & WEAR,  GB NE37 1NE
Applicant Contact L. TODD
Correspondent
ROCKET MEDICAL PLC
WEAR IND. ESTATE DISTRICT 6
WASHINGTON, TYNE & WEAR,  GB NE37 1NE
Correspondent Contact L. TODD
Regulation Number884.1300
Classification Product Code
HES  
Date Received02/03/2000
Decision Date 04/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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