The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Genotropin Mixer.
| Device ID | K954337 |
| 510k Number | K954337 |
| Device Name: | GENOTROPIN MIXER |
| Classification | Syringe, Piston |
| Applicant | PHARMACIA, INC. P.O. BOX 16529 Columbus, OH 43216 -6529 |
| Contact | Susan M Mondabaugh |
| Correspondent | Susan M Mondabaugh PHARMACIA, INC. P.O. BOX 16529 Columbus, OH 43216 -6529 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-11-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GENOTROPIN MIXER 74721729 2283489 Live/Registered |
PFIZER HEALTH AB 1995-08-28 |