510(k) K902285
K902285 is an FDA 510(k) premarket notification submitted by Applied Biomaterial Technologies for the device "THE MAGNUM CHIN IMPLANT". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Applied Biomaterial Technologies has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1990
- Date Received
- May 22, 1990
- 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