The following data is part of a premarket notification filed by E.m. Adams with the FDA for I.v. Start Kit & Obstetrical Kit.
| Device ID | K843724 |
| 510k Number | K843724 |
| Device Name: | I.V. START KIT & OBSTETRICAL KIT |
| Classification | Drape, Surgical |
| Applicant | E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
| Contact | Richard K Donahue |
| Correspondent | Richard K Donahue E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1985-01-10 |