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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K141255
Device Name SIMEX SUBGLOTTIC ASPIRATION SYSTEM
Applicant
SIMEX MEDIZINTECHNIK GMBH
P.O. BOX 123
TARRYTOWN,  NY  10591
Applicant Contact HAMID KHOSROWSHAHI
Correspondent
SIMEX MEDIZINTECHNIK GMBH
P.O. BOX 123
TARRYTOWN,  NY  10591
Correspondent Contact HAMID KHOSROWSHAHI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/14/2014
Decision Date 09/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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