The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Ls-5 Eptfe Suture.
| Device ID | K163639 |
| 510k Number | K163639 |
| Device Name: | LS-5 EPTFE Suture |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | LSI SOLUTIONS 7796 VICTOR-MENDON RD Victor, NY 14564 |
| Contact | Kevin Bentley |
| Correspondent | Kevin Bentley LSI SOLUTIONS 7796 VICTOR-MENDON RD Victor, NY 14564 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850200006428 | K163639 | 000 |