510(k) K032847
K032847 is an FDA 510(k) premarket notification submitted by Acueity, Inc. for the device "EXCISOR BIOPTOME, MODEL 01-0004". The FDA issued a decision of Substantially Equivalent on September 26, 2003. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Acueity, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2003
- Date Received
- September 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type