510(k) K925234

BEDSIDE CADDY by Researched, Novel Medical Devices (Rn/Md) — Product Code FMI

K925234 is an FDA 510(k) premarket notification submitted by Researched, Novel Medical Devices (Rn/Md) for the device "BEDSIDE CADDY". The FDA issued a decision of Substantially Equivalent on November 19, 1993. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Researched, Novel Medical Devices (Rn/Md) has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1993
Date Received
October 16, 1992
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