The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Revotek Lc.
Device ID | K012542 |
510k Number | K012542 |
Device Name: | REVOTEK LC |
Classification | Sealant, Pit And Fissure, And Conditioner |
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 | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-07 |
Decision Date | 2001-10-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D0470018421 | K012542 | 000 |
14548161062084 | K012542 | 000 |