510(k) K900282

NEEDLE-SHIELD by Macbrud Corp. Medical Div. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1990
Date Received
January 21, 1990
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