510(k) K891327
- Device
- NICKLE-TITANIUM ORTHODONTIC WIRE
- Applicant
- AMERICAN ORTHODONTICS
- 510(k) number
- K891327
- Product code
- FJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-10
- Date received
- 1989-03-10
- Regulation
- 876.5820
- Classification name
- Detector, Air Bubble
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL RIDDLE
- Address
- 1714 Cambridge Ave. Sheboygan WI US 53081 53081
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904992 | MINNILERT AIR DETECTOR | Minntech Corp. | 1991-02-05 |
| K781330 | BLOOD LEVEL DETECTOR-MODEL 7601 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| K780582 | DETECTOR, BUBBLE & FOAM | Hospal Medical Corp. | 1978-06-22 |
| K770857 | DIALYSIS MACHINE, CENTRY II | Cobe Laboratories, Inc. | 1977-10-04 |
Legacy Summary#
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FDA Review#
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