510(k) K905115
K905115 is an FDA 510(k) premarket notification submitted by Douglas James Donaldson Compliance Services for the device "BIOVISION ENDOCULAR PROBE". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code HGF (Source, Abortion Unit, Vacuum), a Class II device regulated under 21 CFR 884.5070. Douglas James Donaldson Compliance Services has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1991
- Date Received
- November 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Abortion Unit, Vacuum
- Device Class
- Class II
- Regulation Number
- 884.5070
- Review Panel
- OB
- Submission Type