510(k) K994272
K994272 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "AUTOMATED CORE BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on January 7, 2000. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Promex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2000
- Date Received
- December 20, 1999
- 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