The following data is part of a premarket notification filed by Sontra Medical Inc. with the FDA for Sonoprep Ultrasonic Skin Permeation System And Topical Anesthetic Kit, Model D2000.
| Device ID | K040525 |
| 510k Number | K040525 |
| Device Name: | SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 |
| Classification | Ultrasound, Skin Permeation |
| Applicant | SONTRA MEDICAL INC. 10 FORGE PARKWAY Franklin, MA 02038 |
| Contact | Albert Farinha |
| Correspondent | Albert Farinha SONTRA MEDICAL INC. 10 FORGE PARKWAY Franklin, MA 02038 |
| Product Code | NRJ |
| CFR Regulation Number | 878.4410 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-01 |
| Decision Date | 2004-08-17 |
| Summary: | summary |