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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
Applicant Contact MICHAEL ZALEEWSKI
Correspondent
INTERSURGICAL, INC.
417 ELECTRONICS PKWY.
LIVERPOOL,  NY  13088
Correspondent Contact MICHAEL ZALEEWSKI
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/16/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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