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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K073600
Device Name COMFORTGEL FULL FACE MASK
Applicant
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact ZITA T YURKOS
Correspondent
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact ZITA T YURKOS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/21/2007
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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