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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, carbon-dioxide, gaseous-phase
510(K) Number K122075
Device Name DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
Applicant
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool,  NY  13088
Contact michael zaleewski
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/17/2012
Decision Date 12/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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