The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Teflon Pledget Suture Buttress.
| Device ID | K811872 |
| 510k Number | K811872 |
| Device Name: | TEFLON PLEDGET SUTURE BUTTRESS |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | ETHICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-08-12 |