510(k) K801554
- Device
- Sterile Cast Padding
- Applicant
- MEDI-SPEC
- 510(k) number
- K801554
- Product code
- HIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-04
- Date received
- 1980-07-08
- Regulation
- 886.1435
- Classification name
- Maxwell Spot, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009973336
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HIX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831829 | KARICKHOFF FLYING CORPUSCLE VIEWER | Surgidev Corp. | 1983-10-19 |