510(k) K871190
K871190 is an FDA 510(k) premarket notification submitted by Anadias, Inc. for the device "ANADIAS ZARA SYSTEM MALAR IMPLANTS". The FDA issued a decision of Substantially Equivalent on April 10, 1987. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Anadias, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1987
- Date Received
- March 24, 1987
- 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