The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aseptimini Unit, Adu-10.
| Device ID | K905401 |
| 510k Number | K905401 |
| Device Name: | ASEPTIMINI UNIT, ADU-10 |
| Classification | Unit, Operative Dental |
| Applicant | ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
| Contact | Glen Kazen |
| Correspondent | Glen Kazen ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-03 |
| Decision Date | 1991-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817417021620 | K905401 | 000 |