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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K922187
Device Name COMPACT SPACER
Applicant
Glaxo, Inc.
5 Moore Dr.
P.O. Box 13358
Research Triangle,  NC  27709
Applicant Contact THOMAS A GERDING
Correspondent
Glaxo, Inc.
5 Moore Dr.
P.O. Box 13358
Research Triangle,  NC  27709
Correspondent Contact THOMAS A GERDING
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/11/1992
Decision Date 11/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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