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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bougie, esophageal, ent
510(k) Number K844169
Device Name VOLUMATIC
Applicant
GLAXO, INC.
5 MOORE DR.
P.O. BOX 13358
RESEARCH TRIANGLE,  NC  27709
Applicant Contact DAVID MACFARLANE
Correspondent
GLAXO, INC.
5 MOORE DR.
P.O. BOX 13358
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact DAVID MACFARLANE
Regulation Number874.4420
Classification Product Code
KCD  
Date Received10/25/1984
Decision Date 11/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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