The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-525 Transport Iii Portable Dental System.
| Device ID | K130693 |
| 510k Number | K130693 |
| Device Name: | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | ASEPTICO, INC. 8333 216th St SE Woodinville, WA 98072 |
| Contact | Cherie Tregoning |
| Correspondent | Cherie Tregoning ASEPTICO, INC. 8333 216th St SE Woodinville, WA 98072 |
| Product Code | ELC |
| Subsequent Product Code | EIA |
| Subsequent Product Code | EKX |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-14 |
| Decision Date | 2013-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817417021927 | K130693 | 000 |
| 10817417022306 | K130693 | 000 |
| 10817417022313 | K130693 | 000 |