MOLDED CRANIAL HELMET— 510(k) K012920
Substantially EquivalentFairview Orthopedic Laboratory
FDA 510(k) clearance K012920 for MOLDED CRANIAL HELMET, Substantially Equivalent on 2001-11-28. Applicant: Fairview Orthopedic Laboratory.
Clearance details
- Applicant
- Fairview Orthopedic Laboratory
- Product code
- Code MVA
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.