The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for The Red Cap.
| Device ID | K820454 |
| 510k Number | K820454 |
| Device Name: | THE RED CAP |
| Classification | Syringe, Piston |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-18 |
| Decision Date | 1982-03-08 |