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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 K981910
Device Name SUCTION CATHETER
Applicant
NI-MED, INC.
1601 AIR PARK DR.
P.O. BOX 871
FARMINGTON,  MO  63640
Applicant Contact MICHAEL GIBLIN
Correspondent
NI-MED, INC.
1601 AIR PARK DR.
P.O. BOX 871
FARMINGTON,  MO  63640
Correspondent Contact MICHAEL GIBLIN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/01/1998
Decision Date 08/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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