The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Suture Lock.
Device ID | K964935 |
510k Number | K964935 |
Device Name: | SUTURE LOCK |
Classification | Retention Device, Suture |
Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
Contact | Susan A Finneran |
Correspondent | Susan A Finneran SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
Product Code | KGS |
CFR Regulation Number | 878.4930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-10 |
Decision Date | 1997-02-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUTURE LOCK 98021258 not registered Live/Pending |
Universal Tech Corporation 2023-05-31 |
SUTURE LOCK 86637156 not registered Dead/Abandoned |
JULVIA TECHNOLOGIES INC. 2015-05-21 |