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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Argon, Gaseous-Phase
510(k) Number K880442
Device Name BRUSHRITE
Applicant
PRO CARE LABORATORIES, INC.
218 WEST PARK ST.
WEST POINT,  NE  68788
Applicant Contact EUGENE M MUELLER
Correspondent
PRO CARE LABORATORIES, INC.
218 WEST PARK ST.
WEST POINT,  NE  68788
Correspondent Contact EUGENE M MUELLER
Regulation Number868.1075
Classification Product Code
JEG  
Date Received02/02/1988
Decision Date 05/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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