The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Membragel.
| Device ID | K082111 |
| 510k Number | K082111 |
| Device Name: | STRAUMANN MEMBRAGEL |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Lisa Quaglia |
| Correspondent | Lisa Quaglia 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 | 2008-07-28 |
| Decision Date | 2009-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031726834 | K082111 | 000 |
| 07630031700148 | K082111 | 000 |