Sterile Cast Padding
FDA 510(k) K801554 · Medi-Spec
510(k) numberK801554
Submission
- Device name
- Sterile Cast Padding
- Applicant
- Medi-Spec
Mchenry, IL, US - Received
- July 8, 1980
- Decision date
- August 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIX – Maxwell Spot, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1435
- Specialty
- Ophthalmic
Other 510(k)s with product code HIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831829 | Karickhoff Flying Corpuscle ViewerHIX · Traditional | Surgidev Corp. | 10/19/1983SE |
More from Surgidev Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K833068 | Laminaria Japonica Cervical DilatorHDY · Traditional | 02/04/1984SE |
| K812694 | Whisk-RGEE · Traditional | 10/26/1981SE |
| K812426 | Uterine Aspiration Curettes(Rigid&Flex)HHK · Traditional | 10/08/1981SE |
| K800404 | Medspec Operative Opthalmic KitHMP · Traditional | 04/24/1980SE |
| K800490 | Sterile Dressing PackKKX · Traditional | 03/12/1980SE |
| K790952 | Clamp CoversGAD · Traditional | 06/05/1979SE |
| K780548 | Disposa-LoopsKKX · Traditional | 08/21/1978SE |
Questions and answers
When was Sterile Cast Padding cleared by the FDA?
Sterile Cast Padding (K801554) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 27 days after the submission was received.
What is the product code of K801554?
The FDA product code is HIX – Maxwell Spot, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1435.