510(k) K083352
- Device
- VEINWAVE, TC3000
- Applicant
- NEWLANDS CLINICAL TRIALS LTD
- 510(k) number
- K083352
- Product code
- ONQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-12
- Date received
- 2008-11-13
- Regulation
- 878.4400
- Classification name
- Electrosurgical Coagulation For Aesthetic
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM GREENROSE
- Address
- 220 River Rd. Claremont NH US 03743 03743
FDA Registration Numbers#
- 3008816935
- 3008264458
- 3005941719
- 3010709436
- 3010363436
Source Documents#
Other 510(k) Records For Product Code ONQ #
Legacy Summary#
summary
FDA Review#
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