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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 K040417
FOIA Releasable 510(k) K040417
Device Name PILLAR PALATAL IMPLANT SYSTEM
Applicant
RESTORE MEDICAL INC.
2800 PATTON RD.
ST PAUL,  MN  55113
Applicant Contact EDWARD W NUMAINVILLE
Correspondent
RESTORE MEDICAL INC.
2800 PATTON RD.
ST PAUL,  MN  55113
Correspondent Contact EDWARD W NUMAINVILLE
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/18/2004
Decision Date 07/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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