510(k) K950897
K950897 is an FDA 510(k) premarket notification submitted by Biosystems for the device "BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Biosystems has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1995
- Date Received
- February 27, 1995
- 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