EXCELSIOR SINGLE LEAD DISPENSING SET
FDA 510(k) clearance K913804 · decided 1992-02-11
Clearance details
- K-number
- K913804
- Device name
- EXCELSIOR SINGLE LEAD DISPENSING SET
- Applicant
- Excel Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-26
- Decision date
- 1992-02-11
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Asbury Park, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing recall (Z-2070-2014) | Excelsior Medical Corp | 2014-07-16 |