The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Terumo Disposable Spinal Needle.
| Device ID | K760775 |
| 510k Number | K760775 |
| Device Name: | TERUMO DISPOSABLE SPINAL NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-04 |
| Decision Date | 1976-11-01 |