The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for 4631 Duo Delivery System.
Device ID | K000966 |
510k Number | K000966 |
Device Name: | 4631 DUO DELIVERY SYSTEM |
Classification | Unit, Operative Dental |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | Lovena Standridge |
Correspondent | Lovena Standridge 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 | 2000-03-27 |
Decision Date | 2000-05-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10194665000462 | K000966 | 000 |