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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K120079
Device Name PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
Applicant
Primed Halberstadt Medizintechnik GmbH
Strasse Des 20. Juli Nr.1
Halberstadt,  DE 38820
Applicant Contact ALEXANDRA SINGER
Correspondent
Primed Halberstadt Medizintechnik GmbH
Strasse Des 20. Juli Nr.1
Halberstadt,  DE 38820
Correspondent Contact ALEXANDRA SINGER
Regulation Number868.5800
Classification Product Code
BTO  
Date Received01/10/2012
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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