HEM-O-LOK XL CLIP
FDA 510(k) clearance K030311 · decided 2003-02-26
Clearance details
- K-number
- K030311
- Device name
- HEM-O-LOK XL CLIP
- Applicant
- Weck
- Decision
- Substantially Equivalent
- Date received
- 2003-01-30
- Decision date
- 2003-02-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size, non-absorbable po recall (Z-1098-06) | Teleflex Medical | 2006-06-09 |