SUCTION CATHETER TRAY PRODUCT NO. 900277
FDA 510(k) clearance K964011 · decided 1996-11-25
Clearance details
- K-number
- K964011
- Device name
- SUCTION CATHETER TRAY PRODUCT NO. 900277
- Applicant
- Customed, Inc.
- Decision
- Unknown
- Date received
- 1996-10-07
- Decision date
- 1996-11-25
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LRO
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Suction Catheter Kit, catalog# 900-277 recall (Z-1256-2012) | Customed, Inc | 2012-03-21 |