The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for 3181 Duo Delivery System.
| Device ID | K000968 |
| 510k Number | K000968 |
| Device Name: | 3181 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 |
|---|---|---|
| 10194665001414 | K000968 | 000 |
| 10194665002961 | K000968 | 000 |
| 10194665005122 | K000968 | 000 |