ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER
FDA 510(k) clearance K060183 · decided 2006-02-16
Clearance details
- K-number
- K060183
- Device name
- ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-24
- Decision date
- 2006-02-16
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.