510(k) K071630
K071630 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "TERUMO 31G THINPRO INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on July 11, 2007. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2007
- Date Received
- June 14, 2007
- Clearance Type
- Special
- 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