510(k) K841515
- Device
- SCANLAN VASCU-STATT II
- Applicant
- SCANLAN INTL., INC.
- 510(k) number
- K841515
- Product code
- HRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-06-05
- Date received
- 1984-04-12
- Regulation
- 886.4070
- Classification name
- Engine, Trephine, Accessories, 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | 2001-12-14 |
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | 1998-06-23 |
| K843957 | ULTRATHIN/SP LENS | Optical Systems Intl., Inc. | 1985-07-31 |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | 1983-01-17 |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | 1979-11-05 |
Legacy Summary#
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FDA Review#
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