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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 K902281
Device Name MODIFIED SCOOP TRANSTRACHEAL CATHETERS
Applicant
TRANSTRACHEAL SYSTEMS
8755 EAST ORCHARD ROAD,
STE.607
ENGLEWOOD,  CO  80111
Applicant Contact W PETERSON
Correspondent
TRANSTRACHEAL SYSTEMS
8755 EAST ORCHARD ROAD,
STE.607
ENGLEWOOD,  CO  80111
Correspondent Contact W PETERSON
Regulation Number868.5800
Classification Product Code
BTO  
Date Received05/22/1990
Decision Date 08/10/1990
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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