The following data is part of a premarket notification filed by Douglas James Donaldson Compliance Services with the FDA for Biovision Endocular Probe.
| Device ID | K905115 |
| 510k Number | K905115 |
| Device Name: | BIOVISION ENDOCULAR PROBE |
| Classification | Source, Abortion Unit, Vacuum |
| Applicant | DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland, CA 94621 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES 100 HEGENBERGER ROAD, SUITE 210 Oakland, CA 94621 |
| Product Code | HGF |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1991-02-11 |