The following data is part of a premarket notification filed by James J. Schramm with the FDA for I.v. Start Kit.
| Device ID | K950686 |
| 510k Number | K950686 |
| Device Name: | I.V. START KIT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | JAMES J. SCHRAMM P.O. BOX 406 Lake Villa, IL 60046 |
| Contact | James J Schramm |
| Correspondent | James J Schramm JAMES J. SCHRAMM P.O. BOX 406 Lake Villa, IL 60046 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-14 |
| Decision Date | 1996-10-24 |