510(k) K010589
- Device
- MICROWAVAE DELIVERY SYSTEM #MW2000
- Applicant
- MW MEDICAL, INC.
- 510(k) number
- K010589
- Product code
- MWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-19
- Date received
- 2001-02-27
- Regulation
- 878.4400
- Classification name
- System, Microwave, Hair Removal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GREG HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
FDA Registration Numbers#
- 3008082710
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MWY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991456 | MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 | Microwave Medical, Inc. | 1999-10-25 |
Legacy Summary#
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FDA Review#
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