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510(k) K950899

LABORATORY SHARPS BARREL by Biosystems — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1995
Date Received
February 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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