The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Susceptibility Disk, Cinoxacin 100 Mcg..
Device ID | K792349 |
510k Number | K792349 |
Device Name: | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. |
Classification | Chromatographic, Phospholipids |
Applicant | PFIZER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JNT |
CFR Regulation Number | 862.1575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1980-03-12 |