NICKLE-TITANIUM ORTHODONTIC WIRE
FDA 510(k) clearance K891327 · decided 1989-05-10
Clearance details
- K-number
- K891327
- Device name
- NICKLE-TITANIUM ORTHODONTIC WIRE
- Applicant
- American Orthodontics
- Decision
- Substantially Equivalent
- Date received
- 1989-03-10
- Decision date
- 1989-05-10
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- FJF
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sheboygan, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MINNILERT AIR DETECTOR (K904992) | Minntech Corp. | 1991-02-05 |
| BLOOD LEVEL DETECTOR-MODEL 7601 (K781330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| DETECTOR, BUBBLE & FOAM (K780582) | Hospal Medical Corp. | 1978-06-22 |
| DIALYSIS MACHINE, CENTRY II (K770857) | Cobe Laboratories, Inc. | 1977-10-04 |
Recalls involving this device
No recalls on record reference this clearance.