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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K811955
Device Name CALIBRATED BREATHING SYSTEM COLLECTION
Applicant
ANCHOR BRUSH CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ANCHOR BRUSH CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received07/01/1981
Decision Date 08/04/1981
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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