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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Colony Counter
510(k) Number K893519
Device Name TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
Applicant
STATLABS, INC.
169 LONDON LN.
FRANKLIN,  TN  37064
Applicant Contact ANDY WOODS
Correspondent
STATLABS, INC.
169 LONDON LN.
FRANKLIN,  TN  37064
Correspondent Contact ANDY WOODS
Regulation Number866.2170
Classification Product Code
KZB  
Date Received05/08/1989
Decision Date 08/15/1989
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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