SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
FDA 510(k) clearance K040525 · decided 2004-08-17
Clearance details
- K-number
- K040525
- Device name
- SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
- Applicant
- Sontra Medical, Inc.
- Decision
- Unknown
- Date received
- 2004-03-01
- Decision date
- 2004-08-17
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- NRJ
- Device class
- 2
- Regulation number
- 878.4410
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Franklin, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.