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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K170663
Device Name Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Applicant
Foremount Enterprise Co., Ltd.
No. 17, Alley 15, Lane 5, Shenan St., Shengang Dist.,
Taichung City,  TW 42944
Applicant Contact John Yang
Correspondent
MDVentures
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5915
Classification Product Code
BTM  
Subsequent Product Codes
BYE   CAP  
Date Received03/06/2017
Decision Date 05/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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