The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for E-type Straight Handpiece, Model Ahp-101.
| Device ID | K051077 |
| 510k Number | K051077 |
| Device Name: | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-27 |
| Decision Date | 2005-05-03 |
| Summary: | summary |