510(k) K952709
K952709 is an FDA 510(k) premarket notification submitted by Spirit Ridge Technologies for the device "PROTHESIS, CHIN, INTERNAL". The FDA issued a decision of Substantially Equivalent on August 28, 1995. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Spirit Ridge Technologies has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1995
- Date Received
- June 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Nose, Internal
- Device Class
- Class II
- Regulation Number
- 878.3680
- Review Panel
- SU
- Submission Type