The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Ortho Lc.
Device ID | K981461 |
510k Number | K981461 |
Device Name: | GC FUJI ORTHO LC |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Contact | Terry L Joritz |
Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-23 |
Decision Date | 1998-06-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D6584230081 | K981461 | 000 |
00386040009808 | K981461 | 000 |
20386040009796 | K981461 | 000 |
20386040009697 | K981461 | 000 |
20386040009680 | K981461 | 000 |
00386040008658 | K981461 | 000 |
14548161072601 | K981461 | 000 |
24548161283240 | K981461 | 000 |
24548161283035 | K981461 | 000 |