The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for U-100 Insulin Syringe.
| Device ID | K822083 |
| 510k Number | K822083 |
| Device Name: | U-100 INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-12 |
| Decision Date | 1982-08-16 |