510(k) K013151
- Device
- ASMOTOM AUTOMATED TREPHINE SYSTEM
- Applicant
- Bkg Opthalmics USA, Inc.
- 510(k) number
- K013151
- Product code
- HRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-14
- Date received
- 2001-09-20
- Regulation
- 886.4070
- Classification name
- Engine, Trephine, Accessories, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- ART WARD
- Address
- 962 Allegro Ln. Appollo Beach FL US 33572 33572
Source Documents#
Other 510(k) Records For Product Code HRG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | 1998-06-23 |
| K843957 | ULTRATHIN/SP LENS | Optical Systems Intl., Inc. | 1985-07-31 |
| K841515 | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | 1984-06-05 |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | 1983-01-17 |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | 1979-11-05 |