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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 K061261
Device Name L4 OXYGEN CONCENTRATOR
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact ZITA A YURKO
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact ZITA A YURKO
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/05/2006
Decision Date 06/28/2006
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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