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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, nasal, oxygen
510(k) Number K844084
Device Name POLYVINYL CHLORIDE CANNULAS
Applicant
HUDSON EXTRUSIONS, INC.
P.O. BOX 255
HUDSON,  OH  44236
Applicant Contact DEWEY HANSEN
Correspondent
HUDSON EXTRUSIONS, INC.
P.O. BOX 255
HUDSON,  OH  44236
Correspondent Contact DEWEY HANSEN
Regulation Number868.5340
Classification Product Code
CAT  
Date Received10/19/1984
Decision Date 10/30/1984
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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