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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K092648
Device Name RESPIRONICS PERFORMAX SE TOTAL FACE MASK
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 GOLDEN MILE HWY
MONROEVILLE,  PA  15146
Applicant Contact ZITA A YURKO
Correspondent
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 GOLDEN MILE HWY
MONROEVILLE,  PA  15146
Correspondent Contact ZITA A YURKO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/28/2009
Decision Date 12/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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