510(k) K900082
K900082 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "MAXX 470 CORE BIOPSY GUN". The FDA issued a decision of Substantially Equivalent on June 27, 1990. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Dlp, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1990
- Date Received
- January 5, 1990
- 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