510(k) K983750

DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER by Deroyal Industries, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1998
Date Received
October 23, 1998
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