The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Temp.
Device ID | K101420 |
510k Number | K101420 |
Device Name: | GC FUJI TEMP |
Classification | Cement, Dental |
Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Contact | Mark Heiss |
Correspondent | Mark Heiss GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-20 |
Decision Date | 2010-09-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10386040009393 | K101420 | 000 |
14548161282536 | K101420 | 000 |