The following data is part of a premarket notification filed by Ethicon Inc with the FDA for Ultrapro Mesh And Ultrapro Advanced.
Device ID | K180910 |
510k Number | K180910 |
Device Name: | ULTRAPRO Mesh And ULTRAPRO ADVANCED |
Classification | Mesh, Surgical, Polymeric |
Applicant | Ethicon Inc Route 22 West P.O Box 151 Somerville, NJ 08876 |
Contact | Melina Escobar |
Correspondent | Melina Escobar Ethicon Inc Route 22 West P.O Box 151 Somerville, NJ 08876 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-06 |
Decision Date | 2018-07-02 |