510(k) K040525
- Device
- SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
- Applicant
- SONTRA MEDICAL INC.
- 510(k) number
- K040525
- Product code
- NRJ
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2004-08-17
- Date received
- 2004-03-01
- Regulation
- 878.4410
- Classification name
- Ultrasound, Skin Permeation
- 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
- ALBERT FARINHA
- Address
- 10 Forge Pkwy. Franklin MA US 02038 02038
FDA Registration Numbers#
- 3018994966
- 3043140693
Source Documents#
Legacy Summary#
summary
FDA Review#
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