The following data is part of a premarket notification filed by James Leckey Design with the FDA for James Leckey Free Stander.
Device ID | K944308 |
510k Number | K944308 |
Device Name: | JAMES LECKEY FREE STANDER |
Classification | Table, Mechanical |
Applicant | JAMES LECKEY DESIGN 360 MERRIMACK ST., BLDG. 9 Lawrence, MA 01843 |
Contact | James J Falls |
Correspondent | James J Falls JAMES LECKEY DESIGN 360 MERRIMACK ST., BLDG. 9 Lawrence, MA 01843 |
Product Code | INW |
CFR Regulation Number | 890.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-02 |
Decision Date | 1994-12-22 |