510(k) K853282
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1985
- Date Received
- August 5, 1985
- 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