510(k) K973575
K973575 is an FDA 510(k) premarket notification submitted by Hanson Medical, Inc. for the device "DURALASTIC ANATOMICAL CHIN IMPLANTS". The FDA issued a decision of Substantially Equivalent on November 7, 1997. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Hanson Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1997
- Date Received
- September 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Chin, Internal
- Device Class
- Class II
- Regulation Number
- 878.3550
- Review Panel
- SU
- Submission Type