510(k) K063666
K063666 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "SHARPS CONTAINER, MODEL 039-413". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2007
- Date Received
- December 11, 2006
- 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