HAWAIIAN SUPRACONDYLAR PLATE
FDA 510(k) clearance K903697 · decided 1991-01-15
Clearance details
- K-number
- K903697
- Device name
- HAWAIIAN SUPRACONDYLAR PLATE
- Applicant
- Medpac
- Decision
- Substantially Equivalent
- Date received
- 1990-08-15
- Decision date
- 1991-01-15
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.