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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 K922749
Device Name LOW PROFILE TRACHEOSTOMY TUBE
Applicant
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/08/1992
Decision Date 09/02/1992
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
Recalls CDRH Recalls
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