HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
FDA 510(k) clearance K993157 · decided 1999-12-17
Clearance details
- K-number
- K993157
- Device name
- HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
- Applicant
- Weck Closure Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-09-21
- Decision date
- 1999-12-17
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Research Triangle Park, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, R recall (Z-0078-2013) | Teleflex Medical | 2012-10-18 |