510(k) K812744
K812744 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER". The FDA issued a decision of Substantially Equivalent on December 3, 1981. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Progress Mankind Technology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1981
- Date Received
- September 29, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type