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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number878.4410
Classification Product Code
NRJ  
Date Received03/01/2004
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
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