ULNAR HEAD PROTHESIS— 510(k) K790125
Substantially EquivalentCutter Laboratories, Inc.
FDA 510(k) clearance K790125 for ULNAR HEAD PROTHESIS, Substantially Equivalent on 1979-02-08. Applicant: Cutter Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Cutter Laboratories, Inc.
- Product code
- Code KXE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3810
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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