The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Performer Control Unit.
| Device ID | K960506 |
| 510k Number | K960506 |
| Device Name: | A-DEC PERFORMER CONTROL UNIT |
| Classification | Unit, Operative Dental |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Patirck Ridenour |
| Correspondent | Patirck 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 | 1996-02-05 |
| Decision Date | 1996-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10194665000516 | K960506 | 000 |
| 10194665000530 | K960506 | 000 |