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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Gas Generating
510(k) Number K853534
Device Name BBL CAMPY POUCH
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received08/23/1985
Decision Date 08/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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