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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K091191
Device Name GAS TRANSFILL
Applicant
Respironics Inc., Sleep & Home Respiratory Group
1740 Golden Mile Hwy.
Murrysville,  PA  15146
Applicant Contact ZITA A YURKO
Correspondent
Respironics Inc., Sleep & Home Respiratory Group
1740 Golden Mile Hwy.
Murrysville,  PA  15146
Correspondent Contact ZITA A YURKO
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/23/2009
Decision Date 10/23/2009
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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