510(k) K944308

JAMES LECKEY FREE STANDER by James Leckey Design — Product Code INW

K944308 is an FDA 510(k) premarket notification submitted by James Leckey Design for the device "JAMES LECKEY FREE STANDER". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. James Leckey Design has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type