510(k) K863941
K863941 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "POREX(TM) PROSTHESIS, CHIN, INTERNAL". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Porex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1986
- Date Received
- October 10, 1986
- 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