510(k) K953399
K953399 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "NEEDLE OR CUTTER". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1995
- Date Received
- July 20, 1995
- 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