The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Radius 2122/2132.
Device ID | K940893 |
510k Number | K940893 |
Device Name: | A-DEC RADIUS 2122/2132 |
Classification | Unit, Operative Dental |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | Patrick Ridenour |
Correspondent | Patrick Ridenour A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-25 |
Decision Date | 1994-07-12 |