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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 K895162
Device Name TRAUMAFUSE TRACH SHIELD
Applicant
The Traumafuse Co.
2340 Riverbend Rd.
Allentown,  PA  18103
Applicant Contact ROBERT DOUP
Correspondent
The Traumafuse Co.
2340 Riverbend Rd.
Allentown,  PA  18103
Correspondent Contact ROBERT DOUP
Regulation Number868.5800
Classification Product Code
BTO  
Date Received08/22/1989
Decision Date 01/09/1990
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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