The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aseptico Vct Versatile Command Technology Model Aeu-925.
| Device ID | K030163 |
| 510k Number | K030163 |
| Device Name: | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Charles F Mack UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-16 |
| Decision Date | 2003-03-03 |
| Summary: | summary |