The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Amc-20 Portable Dental Cart Model Amc-20.
| Device ID | K101332 |
| 510k Number | K101332 |
| Device Name: | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 |
| Classification | Unit, Operative Dental |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Cherie A Tregoning |
| Correspondent | Cherie A Tregoning 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 | 2010-05-12 |
| Decision Date | 2011-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817417022337 | K101332 | 000 |
| 10817417022320 | K101332 | 000 |