The following data is part of a premarket notification filed by Ethicon Inc (on Behalf Of Omrix Biopharaceuticals with the FDA for Evicel Application Device.
| Device ID | K130900 |
| 510k Number | K130900 |
| Device Name: | EVICEL APPLICATION DEVICE |
| Classification | Syringe, Piston |
| Applicant | ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Shikha Gola |
| Correspondent | Shikha Gola ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2013-08-13 |
| Summary: | summary |