The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Lpg 5/10, Lpg 10/5, Lpg 10/15 And Lpg 15/10.
Device ID | K940749 |
510k Number | K940749 |
Device Name: | LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10 |
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 | 1994-02-18 |
Decision Date | 1994-03-28 |