The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Pac I Portable Unit.
| Device ID | K903451 |
| 510k Number | K903451 |
| Device Name: | A-DEC PAC I PORTABLE UNIT |
| Classification | Unit, Operative Dental |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Pat Ridenour |
| Correspondent | Pat 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 | 1990-07-31 |
| Decision Date | 1990-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10194665004392 | K903451 | 000 |