MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
FDA 510(k) clearance K013348 · decided 2001-10-26
Clearance details
- K-number
- K013348
- Device name
- MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-09
- Decision date
- 2001-10-26
- Days to decision
- 17 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.