The following data is part of a premarket notification filed by Mw Medical, Inc. with the FDA for Microwavae Delivery System #mw2000.
| Device ID | K010589 |
| 510k Number | K010589 |
| Device Name: | MICROWAVAE DELIVERY SYSTEM #MW2000 |
| Classification | System, Microwave, Hair Removal |
| Applicant | MW MEDICAL, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland MW MEDICAL, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MWY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2001-03-19 |