The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-14cf Expendition.
| Device ID | K050201 |
| 510k Number | K050201 |
| Device Name: | AEU-14CF EXPENDITION |
| Classification | Unit, Operative Dental |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Melissa J Deguia UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-28 |
| Decision Date | 2005-03-18 |
| Summary: | summary |