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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sampler, blood, fetal
510(k) Number K810028
Device Name FETAL BLOOD SAMPLING KIT MODEL 1560
Applicant
TRANSIDYNE GENERAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRANSIDYNE GENERAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1560
Classification Product Code
HGW  
Date Received01/06/1981
Decision Date 01/16/1981
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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