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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K033822
Device Name RESPIRONICS CUSTOM I ORAL APPLIANCE
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 Number872.5570
Classification Product Code
LRK  
Date Received12/10/2003
Decision Date 02/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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