510(k) K832662
K832662 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "DENTAL SYRINGE SYSTEM-VARIOUS STYLES". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code KXR (Applicator, Resin), a Class I device regulated under 21 CFR 872.3140. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1983
- Date Received
- August 8, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Resin
- Device Class
- Class I
- Regulation Number
- 872.3140
- Review Panel
- DE
- Submission Type