MICROWAVAE DELIVERY SYSTEM #MW2000
FDA 510(k) clearance K010589 · decided 2001-03-19
Clearance details
- K-number
- K010589
- Device name
- MICROWAVAE DELIVERY SYSTEM #MW2000
- Applicant
- Mw Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-27
- Decision date
- 2001-03-19
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- MWY
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 (K991456) | Microwave Medical, Inc. | 1999-10-25 |
Recalls involving this device
No recalls on record reference this clearance.