FDA 510(k) Applications Submitted by MICHAEL ZALEWSKI

FDA 510(k) Number Submission Date Device Name Applicant
K121026 04/04/2012 FLO-GUARD BREATHING FILTER INTERSURGICAL, INC.
K141087 04/28/2014 INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF INTERSURGICAL INCORPORATED
K121747 06/14/2012 FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS INTERSURGICAL INCORPORATED
K132143 07/11/2013 EXHALATION VALVE INTERSURGICAL INCORPORATED
K092129 07/15/2009 INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 INTERSURGICAL, INC.
K122077 07/16/2012 MANOMETER INTERSURGICAL, INC.
K032322 07/28/2003 CLEAR-THERM MICRO HME, MODEL 1441 INTERSURGICAL, INC.
K092409 08/06/2009 HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER INTERSURGICAL, INC.
K092451 08/10/2009 INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER INTERSURGICAL, INC.


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