510(k) K943740
K943740 is an FDA 510(k) premarket notification submitted by Premium Plastics, Inc. for the device "ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)". The FDA issued a decision of Substantially Equivalent on December 14, 1994. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Premium Plastics, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1994
- Date Received
- August 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type