The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Glass Syringes, Drug, Luer Lock.
| Device ID | K820384 |
| 510k Number | K820384 |
| Device Name: | GLASS SYRINGES, DRUG, LUER LOCK |
| Classification | Syringe, Piston |
| Applicant | PROCEDURE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-04-15 |