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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 K902687
Device Name STERI-CATH-DL
Applicant
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/19/1990
Decision Date 08/29/1990
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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