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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K901803
Device Name SYRINGE NEEDLE INTRODUCER
Applicant
Glaxo, Inc.
5 Moore Dr.
P.O. Box 13358
Research Triangle,  NC  27709
Applicant Contact JAMES E MURRAY
Correspondent
Glaxo, Inc.
5 Moore Dr.
P.O. Box 13358
Research Triangle,  NC  27709
Correspondent Contact JAMES E MURRAY
Regulation Number880.6920
Classification Product Code
KZH  
Date Received04/19/1990
Decision Date 11/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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