STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
FDA 510(k) clearance K053120 · decided 2005-12-09
Clearance details
- K-number
- K053120
- Device name
- STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
- Applicant
- Excelsior Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-07
- Decision date
- 2005-12-09
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Neptune, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Exce recall (Z-0973-2009) | Excelsior Medical Corp | 2009-02-06 |