Device Classification Name |
Ultrasound, Skin Permeation
|
510(k) Number |
K040525 |
Device Name |
SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 |
Applicant |
SONTRA MEDICAL INC. |
10 FORGE PARKWAY |
FRANKLIN,
MA
02038
|
|
Applicant Contact |
ALBERT FARINHA |
Correspondent |
SONTRA MEDICAL INC. |
10 FORGE PARKWAY |
FRANKLIN,
MA
02038
|
|
Correspondent Contact |
ALBERT FARINHA |
Regulation Number | 878.4410
|
Classification Product Code |
|
Date Received | 03/01/2004 |
Decision Date | 08/17/2004 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|