510(k) K082110
K082110 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "DUAL SYRINGE HOLDER". The FDA issued a decision of Substantially Equivalent on June 17, 2009. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2009
- Date Received
- July 28, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stopcock, I.V. Set
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type