510(k) K031339
K031339 is an FDA 510(k) premarket notification submitted by Mallinckrodt Inc., Liebel-Flarsheim Business for the device "OPTIBOLUS". The FDA issued a decision of Substantially Equivalent on July 11, 2003. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Inc., Liebel-Flarsheim Business has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2003
- Date Received
- April 28, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type