The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Hypodermic Syringe.
| Device ID | K771205 |
| 510k Number | K771205 |
| Device Name: | HYPODERMIC SYRINGE |
| Classification | Syringe, Piston |
| Applicant | TERUMO AMERICA, 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 | 1977-07-05 |
| Decision Date | 1977-07-14 |