510(k) K981850
K981850 is an FDA 510(k) premarket notification submitted by Silimed, LLC for the device "SILIMED CHIN IMPLANTS". The FDA issued a decision of Substantially Equivalent on July 9, 1998. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Silimed, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1998
- Date Received
- May 26, 1998
- 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