The following data is part of a premarket notification filed by Mjm International Corporation with the FDA for Model 418 Series Walkers.
| Device ID | K053192 |
| 510k Number | K053192 |
| Device Name: | MODEL 418 SERIES WALKERS |
| Classification | Walker, Mechanical, Poly Vinyl Chloride (pvc) |
| Applicant | MJM INTERNATIONAL CORPORATION 2003 N. I RD., STE. 10 San Juan, TX 78589 |
| Contact | Melly Moroles |
| Correspondent | Melly Moroles MJM INTERNATIONAL CORPORATION 2003 N. I RD., STE. 10 San Juan, TX 78589 |
| Product Code | NXE |
| CFR Regulation Number | 890.3825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2005-12-05 |
| Summary: | summary |