510(k) K912892
K912892 is an FDA 510(k) premarket notification submitted by Angiomed GmbH & Co. Medizintechnik KG for the device "AUTO-VAC BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 7, 1992. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 7, 1992
- Date Received
- Jul 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type
- 510(k)