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510(k) K040525

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 by Sontra Medical, Inc. — Product Code NRJ

Clearance Details

Decision: SESK (Substantially Equivalent (kit))
Decision Date: August 17, 2004
Date Received: March 1, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ultrasound, Skin Permeation
Device Class: Class II
Regulation Number: 878.4410
Review Panel: SU
Submission Type

Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.