510(k) K093915
K093915 is an FDA 510(k) premarket notification submitted by Deka Research & Development Corp. for the device "DEKA TAC DEVICE". The FDA issued a decision of Substantially Equivalent on August 23, 2011. The device falls under product code FIG (Clamp, Tubing, Blood, Automatic), a Class II device regulated under 21 CFR 876.5820. Deka Research & Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2011
- Date Received
- December 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Tubing, Blood, Automatic
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type