TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
FDA 510(k) clearance K042608 · decided 2004-10-18
Clearance details
- K-number
- K042608
- Device name
- TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
- Applicant
- Tecno Instruments (Pvt.) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-24
- Decision date
- 2004-10-18
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.