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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 K173064
Device Name ZAPnea Oral Appliance
Applicant
B. Fareid, Dds, PC
1591 Earl St.
Kingsburg,  CA  93631
Applicant Contact Behzad Fareid
Correspondent
B. Fareid, Dds, PC
1591 Earl St.
Kingsburg,  CA  93631
Correspondent Contact Behzad Fareid
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
KMY  
Date Received09/29/2017
Decision Date 03/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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