510(k) K883884
K883884 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "PROSTATIC CORE-CUT NEEDLE". The FDA issued a decision of Substantially Equivalent on December 5, 1988. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Euro-Med Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1988
- Date Received
- September 13, 1988
- 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