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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tray, blood collection
510(k) Number K760086
Device Name TRAY, BLOOD SAMPLING (PULSATOR II)
Applicant
CONCORD LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
CONCORD LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number862.1675
Classification Product Code
GJE  
Date Received06/21/1976
Decision Date 07/16/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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