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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K872832
Device Name TRACH COLLAR
Applicant
ROTEK CORP.
8401 WASHINGTON STREET, NE
ALBUQUERQUE,  NM  87113
Applicant Contact DALE ZIMMERMAN
Correspondent
ROTEK CORP.
8401 WASHINGTON STREET, NE
ALBUQUERQUE,  NM  87113
Correspondent Contact DALE ZIMMERMAN
Regulation Number868.5770
Classification Product Code
CBH  
Date Received07/17/1987
Decision Date 09/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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