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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K885334
Device Name VAC-RITE
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number880.6740
Classification Product Code
GCX  
Date Received12/28/1988
Decision Date 03/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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