510(k) K014088
K014088 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DUPLOREACH". The FDA issued a decision of Substantially Equivalent on Jun 7, 2002. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 2002
- Date Received
- Dec 12, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)