INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF
FDA 510(k) clearance K003717 · decided 2001-03-01
Clearance details
- K-number
- K003717
- Device name
- INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF
- Applicant
- Tekno Medical Optik-Chirurgie GmbH & Co.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-04
- Decision date
- 2001-03-01
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wurmlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.