NBS CONNECTING TUBE SET
FDA 510(k) clearance K001068 · decided 2000-06-14
Clearance details
- K-number
- K001068
- Device name
- NBS CONNECTING TUBE SET
- Applicant
- Nbs Products CO
- Decision
- Substantially Equivalent
- Date received
- 2000-04-03
- Decision date
- 2000-06-14
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- New Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S recall (Z-2408-2024) | Canadian Hospital Specialties Ltd. | 2024-07-17 |