The following data is part of a premarket notification filed by Synovis Life Technologies. Inc. (a Subsidiary Of Baxter with the FDA for Peri-strips Dry Staple Line Reinforcement With Veritas Collagen Matrix With Secure Grip Technology.
Device ID | K213125 |
510k Number | K213125 |
Device Name: | PERI-STRIPS Dry Staple Line Reinforcement With VERITAS Collagen Matrix With SECURE GRIP Technology |
Classification | Mesh, Surgical |
Applicant | Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W St. Paul, MN 55114 |
Contact | Megan Sajjad |
Correspondent | Megan Sajjad Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W St. Paul, MN 55114 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-27 |
Decision Date | 2021-10-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412658846 | K213125 | 000 |
50085412658785 | K213125 | 000 |