510(k) K941431
K941431 is an FDA 510(k) premarket notification submitted by Bio-Interfaces, Inc. for the device "BONE GRAFT DELIVERY SYRINGES". The FDA issued a decision of Substantially Equivalent on July 12, 1994. The device falls under product code EID (Syringe, Restorative And Impression Material), a Class I device regulated under 21 CFR 872.4565. Bio-Interfaces, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1994
- Date Received
- March 24, 1994
- 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