The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-425 Transport Ii Portable Dental System.
| Device ID | K022217 |
| 510k Number | K022217 |
| Device Name: | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Grant Ramaley ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-08 |
| Decision Date | 2002-10-24 |
| Summary: | summary |