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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 K894096
Device Name STAT-TRACH(TM) VENTILATION CATHETER
Applicant
STATRON CORP.
2624 BEAVER GLEN DR.
ASHLAND,  VA  23005
Applicant Contact ED RANSOM
Correspondent
STATRON CORP.
2624 BEAVER GLEN DR.
ASHLAND,  VA  23005
Correspondent Contact ED RANSOM
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/09/1989
Decision Date 03/16/1990
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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