OSMED EPI-GUIDE
Bone Grafting Material, Synthetic
THM BIOMEDICAL, INC.
The following data is part of a premarket notification filed by Thm Biomedical, Inc. with the FDA for Osmed Epi-guide.
Pre-market Notification Details
| Device ID | K940643 |
| 510k Number | K940643 |
| Device Name: | OSMED EPI-GUIDE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | THM BIOMEDICAL, INC. 325 LAKE AVE. S. STE. #608 Duluth, MN 55802 |
| Contact | David Langley |
| Correspondent | David Langley THM BIOMEDICAL, INC. 325 LAKE AVE. S. STE. #608 Duluth, MN 55802 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-14 |
| Decision Date | 1996-10-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812337027137 | K940643 | 000 |
| 00812337027144 | K940643 | 000 |
Trademark Results [OSMED EPI-GUIDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSMED EPI-GUIDE 74289026 not registered Dead/Abandoned |
THM Biomedical Inc. 1992-06-29 |
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