The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec/biobarrier Membrane.
| Device ID | K974752 |
| 510k Number | K974752 |
| Device Name: | IMTEC/BIOBARRIER MEMBRANE |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Contact | M. K. Patterson |
| Correspondent | M. K. Patterson IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-03 |
| Summary: | summary |