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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K813220
Device Name REGU-VAC OXYGENATING SUCTION CATHETER
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
Date Received11/09/1981
Decision Date 01/22/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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