C-S IMPACTOR
FDA 510(k) clearance K890185 · decided 1989-04-06
Clearance details
- K-number
- K890185
- Device name
- C-S IMPACTOR
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-18
- Decision date
- 1989-04-06
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LYP
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.