510(k) K913974
K913974 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "ACCESS IMPRESSION BARREL". The FDA issued a decision of Substantially Equivalent on February 25, 1992. The device falls under product code EID (Syringe, Restorative And Impression Material), a Class I device regulated under 21 CFR 872.4565. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1992
- Date Received
- September 6, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Restorative And Impression Material
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type