The following data is part of a premarket notification filed by American Mcgaw with the FDA for I.v. Administration Set.
| Device ID | K810757 |
| 510k Number | K810757 |
| Device Name: | I.V. ADMINISTRATION SET |
| Classification | Enteroscope And Accessories |
| Applicant | AMERICAN MCGAW 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-20 |
| Decision Date | 1981-04-08 |