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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K911400
Device Name WALKAWAY TM 40
Applicant
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact KARLA TOMFOHRDE
Correspondent
Baxter Healthcare Corp
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact KARLA TOMFOHRDE
Regulation Number866.1640
Classification Product Code
LRG  
Date Received03/29/1991
Decision Date 11/19/1991
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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