The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Vydax 525-550 & 5100 Fluorotelomer.
| Device ID | K833357 |
| 510k Number | K833357 |
| Device Name: | VYDAX 525-550 & 5100 FLUOROTELOMER |
| Classification | Staple, Removable (skin) |
| Applicant | ETHICON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GDT |
| CFR Regulation Number | 878.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-28 |
| Decision Date | 1983-12-12 |