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 |