The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model Sp5800 #8 French Intro. Kit.
| Device ID | K823262 |
| 510k Number | K823262 |
| Device Name: | MODEL SP5800 #8 FRENCH INTRO. KIT |
| Classification | Introducer, Catheter |
| Applicant | GOULD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-02 |
| Decision Date | 1983-01-18 |