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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Nasal
510(k) Number K181219
Device Name OptiPillows EPAP Mask
Applicant
Cpapnea Medical Supply
10443 N Cave Creek Rd., Suite 110
Phoenix,  AZ  85020
Applicant Contact Sal T. Hakim
Correspondent
Cpapnea Medical Supply
10443 N Cave Creek Rd., Suite 110
Phoenix,  AZ  85020
Correspondent Contact Sal T. Hakim
Regulation Number874.3900
Classification Product Code
LWF  
Date Received05/07/2018
Decision Date 08/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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