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 |