The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Polyurethane Prod. For I.v. Needles.
| Device ID | K771125 |
| 510k Number | K771125 |
| Device Name: | POLYURETHANE PROD. FOR I.V. NEEDLES |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-22 |
| Decision Date | 1977-08-02 |