510(k) K982752
K982752 is an FDA 510(k) premarket notification submitted by Seare Biomedical Corp. for the device "SEARE BIOMEDICAL CHIN IMPLANTS". The FDA issued a decision of Substantially Equivalent on September 30, 1998. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Seare Biomedical Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1998
- Date Received
- August 6, 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