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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 K981080
Device Name SCOOP 1
Applicant
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Applicant Contact LESIS WARD
Correspondent
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Correspondent Contact LESIS WARD
Regulation Number868.5800
Classification Product Code
BTO  
Date Received03/24/1998
Decision Date 06/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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