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 |