Bandage Spreader Block
FDA 510(k) K780227 · Biomet, Inc.
510(k) numberK780227
Submission
- Device name
- Bandage Spreader Block
- Applicant
- Biomet, Inc.
Mchenry, IL, US - Received
- February 9, 1978
- Decision date
- March 15, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILZ – Accessories, Traction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5925
- Specialty
- Physical Medicine
Other 510(k)s with product code ILZ
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|---|---|---|---|
| K921711 | Flexion Distration SupportILZ · Traditional | Altoona Medical Supply | 07/13/1992SE |
| K895382 | Vibra-Trac Traction TableILZ · Traditional | Vibra-Trac Industries | 10/16/1989SE |
| K884340 | AMX-110, Amx-Ii and Amx-IiiILZ · Traditional | Dyna-Med | 01/24/1989SE |
| K852398 | Vector Bar Suspension/Traction UnitILZ · Traditional | Powlan Manufacturing Co. | 08/12/1985SE |
| K844490 | Traction AccessoriesILZ · Traditional | Jerome Medical | 02/21/1985SE |
| K831135 | Saunders #7080 Cervical Traction SysILZ · Traditional | Chattanooga Group, Inc. | 06/24/1983SE |
| K830245 | Head HalterILZ · Traditional | Warm & Form, Orthopedic Materials | 03/09/1983SE |
| K823659 | Pelvic Traction BeltILZ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823166 | Pelvic Traction BeltILZ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K820663 | Boger Auto-Traction DeviceILZ · Traditional | D.C. Medical Device, Inc. | 05/03/1982SE |
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Questions and answers
When was Bandage Spreader Block cleared by the FDA?
Bandage Spreader Block (K780227) received a 510(k) decision of Substantially Equivalent on March 15, 1978, 34 days after the submission was received.
What is the product code of K780227?
The FDA product code is ILZ – Accessories, Traction, a Class I (low risk) device regulated under 21 CFR 890.5925.