510(k) K897095
K897095 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "DISPOSINEEDLE SHARPS DISPOSAL UNIT". The FDA issued a decision of Substantially Equivalent on January 17, 1990. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Specialites Septodont has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1990
- Date Received
- December 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type