ORTHOFIX— 510(k) K831576
Substantially EquivalentElectro-Biology, Inc.
FDA 510(k) clearance K831576 for ORTHOFIX, Substantially Equivalent on 1983-06-08. Applicant: Electro-Biology, Inc.. Device class: 2.
Clearance details
- Applicant
- Electro-Biology, Inc.
- Product code
- Code JEC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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