SAFE LOCK TITANIUM ADAPTER SET
FDA 510(k) clearance K822550 · decided 1982-10-13
Clearance details
- K-number
- K822550
- Device name
- SAFE LOCK TITANIUM ADAPTER SET
- Applicant
- American Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-24
- Decision date
- 1982-10-13
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- FKX
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Freehold, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe recall (Z-0017-05) | Fresenius Medical Care North America | 2004-10-13 |