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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
Predetermined Change
Control Plan Authorized		 No
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