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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pipette, Pasteur
510(k) Number K760899
Device Name STERILE DISPOSABLE COTTON PLUGGED SER.
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number864.6160
Classification Product Code
GJW  
Date Received10/26/1976
Decision Date 11/09/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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