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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 K011723
Device Name ANTI-SNORING DEVICE OR ASD
Applicant
Pi Medical
4050 Olson Menorial Hwy.
Suite 350
Minneapolis,  MN  55422
Applicant Contact LINDA S ALEXANDER
Correspondent
Pi Medical
4050 Olson Menorial Hwy.
Suite 350
Minneapolis,  MN  55422
Correspondent Contact LINDA S ALEXANDER
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/04/2001
Decision Date 12/18/2002
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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