Liebel-Flarsheim Afc 1000 X-Ray Film
FDA 510(k) K841732 · Sybron Corp.
510(k) numberK841732
Submission
- Device name
- Liebel-Flarsheim Afc 1000 X-Ray Film
- Applicant
- Sybron Corp.
Mchenry, IL, US - Received
- April 26, 1984
- Decision date
- June 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K904103 | Sep 90IZP · Traditional | Elema-Schonander, Inc. | 11/20/1990SE |
| K874451 | Omniplane 200 Film Changer SystemIZP · Traditional | Medrad, Inc. | 02/11/1988SE |
| K854251 | The Cse Film Changer SystemIZP · Traditional | Changer Service & Engineering, Inc. | 10/28/1985SE |
| K842903 | Sep Programmer for Puck U & Ud FilmchangIZP · Traditional | Elema-Schonander, Inc. | 08/21/1984SE |
| K841649 | Maximax - 4IZP · Traditional | Cgr Medical Corp. | 06/05/1984SE |
| K840389 | Sep Programmer Sep-M/Single-Plane &IZP · Traditional | Elema-Schonander, Inc. | 02/21/1984SE |
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| K840407 | Kerr Resin Bonded Bridge CementEMA · Traditional | 05/21/1984SE |
| K840607 | LF Motorized Radiographic Film ViewerIXC · Traditional | 03/05/1984SE |
| K833138 | Digital Injector SysDXT · Traditional | 11/14/1983SE |
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Questions and answers
When was Liebel-Flarsheim Afc 1000 X-Ray Film cleared by the FDA?
Liebel-Flarsheim Afc 1000 X-Ray Film (K841732) received a 510(k) decision of Substantially Equivalent on June 5, 1984, 40 days after the submission was received.
What is the product code of K841732?
The FDA product code is IZP – Programmer, Changer, Film/Cassette, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1870.