dermaPACE System
FDA 510(k) clearance DEN160037 · decided 2017-12-28
Clearance details
- K-number
- DEN160037
- Device name
- dermaPACE System
- Applicant
- Sanuwave, Inc.
- Decision
- Unknown
- Date received
- 2016-07-25
- Decision date
- 2017-12-28
- Days to decision
- 521 days
- Clearance type
- Direct
- Product code
- PZL
- Device class
- 2
- Regulation number
- 878.4685
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEALTHTRONICS OSSATRON (P990086/S004) | Sanuwave, Inc. | 2004-08-06 |
| HEALTHTRONICS OSSATRON (P990086/S003) | Sanuwave, Inc. | 2003-03-14 |
| HEALTHTRONICS OSSATRON (P990086/S001) | Sanuwave, Inc. | 2001-05-01 |
| HEALTHTRONICS OSSATRON (P990086/S002) | Sanuwave, Inc. | 2001-03-30 |
| HEALTHTRONICS OSSATRON (P990086) | Sanuwave, Inc. | 2000-10-12 |