510(k) K900433
K900433 is an FDA 510(k) premarket notification submitted by Interphase Implants, Inc. for the device "SMOOTH STAPLE IMPLANT". The FDA issued a decision of SESP on November 16, 1990. The device falls under product code MDL (Implant, Transmandibular), a Class II device regulated under 21 CFR 872.4760.
Clearance Details
- Decision
- SESP ()
- Decision Date
- November 16, 1990
- Date Received
- January 30, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Transmandibular
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type