The following data is part of a premarket notification filed by Lydus Medical Ltd. with the FDA for Vesseal.
Device ID | K221280 |
510k Number | K221280 |
Device Name: | Vesseal |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | Lydus Medical Ltd. 13 Zarhin St. Ra'anana, IL 4366241 |
Contact | Jessica Weiss |
Correspondent | Orly Maor Orly Maor 25 Sirkin Street Kfar Saba, IL 4442156 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-03 |
Decision Date | 2022-12-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VESSEAL 75796556 not registered Dead/Abandoned |
Heuser, Richard R. 1999-09-10 |
VESSEAL 73586029 1475597 Dead/Cancelled |
T J SMITH AND NEPHEW, LIMITED 1986-02-28 |