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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 K181396
Device Name Oral Device OA, Oral Device S
Applicant
Passion For Life Healthcare (Uk) Limited
Pioneer House, Pioneer Business Park N. Rd.
Ellesmere Port,  GB CH65 1AD
Applicant Contact Paul Earps
Correspondent
Passion For Life Healthcare (Uk) Limited
Pioneer House, Pioneer Business Park N. Rd.
Ellesmere Port,  GB CH65 1AD
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/29/2018
Decision Date 11/16/2018
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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