HRG — Engine, Trephine, Accessories, Ac-Powered Class I
FDA Device Classification
Classification Details
- Product Code
- HRG
- Device Class
- Class I
- Regulation Number
- 886.4070
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K013151 | bkg opthalmics usa | ASMOTOM AUTOMATED TREPHINE SYSTEM | December 14, 2001 |
| K981063 | laser center dev | AUTOMATED CORNEAL TREPHINE | June 23, 1998 |
| K843957 | optical systems intl | ULTRATHIN/SP LENS | July 31, 1985 |
| K841515 | scanlan intl | SCANLAN VASCU-STATT II | June 5, 1984 |
| K823901 | edward weck | TREPHINE BLADES-VARIOUS MODELS | January 17, 1983 |
| K791763 | intl. ophthalmic industries | (MICRO-KERATRON, MICRO DUCT TREPHINE) | November 5, 1979 |