The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Reconstitution Accessoreis.
| Device ID | K950861 |
| 510k Number | K950861 |
| Device Name: | RECONSTITUTION ACCESSOREIS |
| Classification | Tubing, Fluid Delivery |
| Applicant | ORGANON, INC. 375 MOUNT PLEASANT AVE. West Orange, NJ 07052 |
| Contact | Albert P Mayo |
| Correspondent | Albert P Mayo ORGANON, INC. 375 MOUNT PLEASANT AVE. West Orange, NJ 07052 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-05-26 |