510(k) K053192
- Device
- MODEL 418 SERIES WALKERS
- Applicant
- MJM INTERNATIONAL CORPORATION
- 510(k) number
- K053192
- Product code
- NXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-05
- Date received
- 2005-11-15
- Regulation
- 890.3825
- Classification name
- Walker, Mechanical, Poly Vinyl Chloride (pvc)
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MELLY MOROLES
- Address
- 2003 N. I Rd., Suite 10 San Juan TX US 78589 78589
FDA Registration Numbers#
- 3003772414
- 3010394125
- 3007218972
- 3016159374
- 3004499949
- 3007518294
Source Documents#
Legacy Summary#
summary
FDA Review#
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