The following data is part of a premarket notification filed by Ortho Pharmaceutical Corp. with the FDA for Pulsatile Pump For Gonadorelin Acetate.
| Device ID | K893488 |
| 510k Number | K893488 |
| Device Name: | PULSATILE PUMP FOR GONADORELIN ACETATE |
| Classification | Pump, Infusion |
| Applicant | ORTHO PHARMACEUTICAL CORP. ROUTE 202, P.O. BOX 300 Raritan, NJ 08869 |
| Contact | J Hume |
| Correspondent | J Hume ORTHO PHARMACEUTICAL CORP. ROUTE 202, P.O. BOX 300 Raritan, NJ 08869 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-04 |
| Decision Date | 1989-10-31 |