FRACTURE REDUCTION SYS., MODEL OR 1001— 510(k) K770388
Substantially EquivalentSisan Assoc.
FDA 510(k) clearance K770388 for FRACTURE REDUCTION SYS., MODEL OR 1001, Substantially Equivalent on 1977-03-14. Applicant: Sisan Assoc.. Device class: 2.
Clearance details
- Applicant
- Sisan Assoc.
- 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
Recent devices under product code JEC
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