510(k) K943644
K943644 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "IMPLANTECH TEMPORAL IMPLANT". The FDA issued a decision of ST on October 18, 1994. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- October 18, 1994
- Date Received
- July 27, 1994
- 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