SPECTRA 724
FDA 510(k) clearance K854498 · decided 1985-11-25
Clearance details
- K-number
- K854498
- Device name
- SPECTRA 724
- Applicant
- Daavlin Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-12
- Decision date
- 1985-11-25
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bryan, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.