The following data is part of a premarket notification filed by Straumann Usa (on Behalf Of Institut Straumann Ag) with the FDA for Straumann Membragel.
| Device ID | K101956 |
| 510k Number | K101956 |
| Device Name: | STRAUMANN MEMBRAGEL |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Janet C Kay |
| Correspondent | Janet C Kay STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-12-16 |
| Summary: | summary |