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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 K904974
Device Name TRACH COLLAR
Applicant
Rotek Corp.
8401 Washington St., NE
Albuquerque,  NM  87113
Applicant Contact ROBERT A O'CONNELL
Correspondent
Rotek Corp.
8401 Washington St., NE
Albuquerque,  NM  87113
Correspondent Contact ROBERT A O'CONNELL
Regulation Number868.5770
Classification Product Code
CBH  
Date Received10/23/1990
Decision Date 01/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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