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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 K060744
Device Name O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
Applicant
O'Brien Dental Lab, Inc.
4311 SW Research Way
Corvallis,  OR  97333
Applicant Contact SUZIE DOWNING
Correspondent
O'Brien Dental Lab, Inc.
4311 SW Research Way
Corvallis,  OR  97333
Correspondent Contact SUZIE DOWNING
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/20/2006
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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