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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name anesthesia conduction kit
510(k) Number K782069
Device Name TRAY, AUXILLARY BLOCK
Applicant
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received12/13/1978
Decision Date 01/04/1979
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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