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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 K170053
Device Name Meridian PM
Applicant
The Center for Craniofacial & Dental Sleep Medicine
4545 Sweetwater Blvd
Sugarland,  TX  77479
Applicant Contact Samuel Cress
Correspondent
FisherMed Consulting LLC
260 Howard Drive
Santa Clara,  CA  95051
Correspondent Contact Cheryl Fisher
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received01/05/2017
Decision Date 11/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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