EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
FDA 510(k) clearance K962938 · decided 1996-10-25
Clearance details
- K-number
- K962938
- Device name
- EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
- Applicant
- Excelsior Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-29
- Decision date
- 1996-10-25
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Long Branch, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Excelsior Medical Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use recall (Z-0035-2011) | Excelsior Medical Corp | 2010-10-20 |