510(k) K962824
K962824 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "IMPLANTECH JEJ PERI-PYRIFORM IMPLANT". The FDA issued a decision of Substantially Equivalent on October 3, 1996. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 1996
- Date Received
- July 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Nose, Internal
- Device Class
- Class II
- Regulation Number
- 878.3680
- Review Panel
- SU
- Submission Type