510(k) K970320
- Device
- Scleral Shell
- Applicant
- XAVIER A. GUERRA, OCULARIST, INC.
- 510(k) number
- K970320
- Product code
- HQT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-07
- Date received
- 1997-01-28
- Regulation
- 886.3800
- Classification name
- Shell, Scleral
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- XAVIER A GUERRA
- Address
- 4640 Centerview Dr. San Antonio TX US 78228 78228
FDA Registration Numbers#
- 2183958
- 2521877
- 3006550126
- 2183957
- 3042953262
- 3007096749
- 2183955
- 3003951061
- 1000220575
- 3042228518
- 2183831
Source Documents#
510(k) summary PDF not indicated by FDA