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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
Predetermined Change
Control Plan Authorized		 No
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