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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K903552
Device Name ORAL-CATH SUCTION CATHETER
Applicant
CONCORD PROTEX
KIT ST.
P.O. BOX 724
KEENE,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
CONCORD PROTEX
KIT ST.
P.O. BOX 724
KEENE,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.6810
Classification Product Code
BSY  
Date Received08/06/1990
Decision Date 01/02/1991
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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