DARWIN KNEE SYSTEM
FDA 510(k) clearance K943462 · decided 1994-12-21
Clearance details
- K-number
- K943462
- Device name
- DARWIN KNEE SYSTEM
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-07-18
- Decision date
- 1994-12-21
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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