The following data is part of a premarket notification filed by American Custom Medical, Inc. with the FDA for Tefgen - Ls.
| Device ID | K965205 |
| 510k Number | K965205 |
| Device Name: | TEFGEN - LS |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | AMERICAN CUSTOM MEDICAL, INC. 2430 NORTH 7TH AVE., #4 Bozeman, MT 59715 |
| Contact | Bruce G Ruefer |
| Correspondent | Bruce G Ruefer AMERICAN CUSTOM MEDICAL, INC. 2430 NORTH 7TH AVE., #4 Bozeman, MT 59715 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-26 |
| Decision Date | 1997-04-30 |
| Summary: | summary |