The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Vera Pdn.
Device ID | K972118 |
510k Number | K972118 |
Device Name: | VERA PDN |
Classification | Alloy, Metal, Base |
Applicant | AALBA DENT, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
Contact | Robert W Bauer |
Correspondent | Robert W Bauer AALBA DENT, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-05 |
Decision Date | 1997-08-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
90852187007180 | K972118 | 000 |
90852187007135 | K972118 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VERA PDN 77311397 3435827 Live/Registered |
Aalba Dent, Inc. 2007-10-23 |