The following data is part of a premarket notification filed by King & Spalding with the FDA for Implantech Midface-submalar Le Fort Implant.
| Device ID | K942420 |
| 510k Number | K942420 |
| Device Name: | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT |
| Classification | Implant, Malar |
| Applicant | KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1994-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724ALIS1 | K942420 | 000 |
| M724ALIM1 | K942420 | 000 |
| M724ALIL1 | K942420 | 000 |