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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anaerobic Box Glove
510(k) Number K920131
Device Name CLARITHROMYCIN 15MCG SENSI DISC
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact RUSSELL ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.2120
Classification Product Code
JTM  
Date Received01/10/1992
Decision Date 02/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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