HALL OSTEON
FDA 510(k) clearance K833187 · decided 1983-10-31
Clearance details
- K-number
- K833187
- Device name
- HALL OSTEON
- Applicant
- Amsco Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-19
- Decision date
- 1983-10-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GET
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.