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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
Predetermined Change
Control Plan Authorized		 No
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