SITE GILLS STYLE I/A HANDPIECE
FDA 510(k) clearance K842459 · decided 1984-08-15
Clearance details
- K-number
- K842459
- Device name
- SITE GILLS STYLE I/A HANDPIECE
- Applicant
- Chiron Vision Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-22
- Decision date
- 1984-08-15
- Days to decision
- 54 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.