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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 and tube cuff
510(k) Number K013728
Device Name TRACH VOX
Applicant
ENGINEERED MEDICAL SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
ENGINEERED MEDICAL SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/09/2001
Decision Date 07/30/2002
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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