UNIVERSAL DRAINAGE TRAY
FDA 510(k) clearance K961442 · decided 1996-05-09
Clearance details
- K-number
- K961442
- Device name
- UNIVERSAL DRAINAGE TRAY
- Applicant
- Customed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-15
- Decision date
- 1996-05-09
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- FCM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Universal drainage kit, catalog# 900-032 recall (Z-1254-2012) | Customed, Inc | 2012-03-21 |
| Urethral Catheter Tray catalog# 900-278 recall (Z-1257-2012) | Customed, Inc | 2012-03-21 |