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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name circuit, breathing (w connector, adaptor, y piece)
510(k) Number K854573
Device Name ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
Applicant
ARTEC ENVIRONMENTAL MONITORING DIVISION
P.O. BOX 68
NOBLESVILLE,  IN  46060
Applicant Contact BILL WINGLER
Correspondent
ARTEC ENVIRONMENTAL MONITORING DIVISION
P.O. BOX 68
NOBLESVILLE,  IN  46060
Correspondent Contact BILL WINGLER
Regulation Number868.5240
Classification Product Code
CAI  
Date Received11/14/1985
Decision Date 01/03/1986
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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