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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K954041
Device Name G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)
Applicant
Glaxo, Inc.
Five Moore Dr.
Research Triangle Park,  NC  27709
Applicant Contact JAMES E MURRAY
Correspondent
Glaxo, Inc.
Five Moore Dr.
Research Triangle Park,  NC  27709
Correspondent Contact JAMES E MURRAY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/29/1995
Decision Date 10/16/1995
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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