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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K042727
Device Name POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
Applicant
FOREMOUNT ENT. CO., LTD.
9F-4, NO.1 LANE 641
SHEN-LIN SOUTH RD.
TA YA HSIANG, TAICHUNG,  TW 428
Applicant Contact TYSON HSU
Correspondent
FOREMOUNT ENT. CO., LTD.
9F-4, NO.1 LANE 641
SHEN-LIN SOUTH RD.
TA YA HSIANG, TAICHUNG,  TW 428
Correspondent Contact TYSON HSU
Regulation Number868.5870
Classification Product Code
CBP  
Date Received10/01/2004
Decision Date 03/18/2005
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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