510(k) K810134
K810134 is an FDA 510(k) premarket notification submitted by Info-Chem for the device "KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Info-Chem has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1981
- Date Received
- January 19, 1981
- 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