The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Vicryl.
Device ID | K810428 |
510k Number | K810428 |
Device Name: | VICRYL |
Classification | Mesh, Surgical, Polymeric |
Applicant | ETHICON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-18 |
Decision Date | 1981-03-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705031056961 | K810428 | 000 |
10705031056954 | K810428 | 000 |
10705031056923 | K810428 | 000 |
10705031056909 | K810428 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VICRYL 74152646 not registered Dead/Abandoned |
JOHNSON & JOHNSON 1991-03-29 |
![]() VICRYL 73323336 1200955 Live/Registered |
Johnson & Johnson 1981-08-12 |
![]() VICRYL 73101304 1065076 Dead/Cancelled |
Sherwin-Williams Company, The 1976-09-27 |
![]() VICRYL 72430937 0957384 Live/Registered |
JOHNSON & JOHNSON 1972-07-27 |