510(k) DEN020001
- Device
- BREASTVIEW VISUAL MAPPING SYSTEM
- Applicant
- Assurance Medical
- 510(k) number
- DEN020001
- Product code
- NKA
- Decision
- Unknown (DENG)
- Decision date
- 2003-01-31
- Date received
- 2002-05-28
- Regulation
- 884.2990
- Classification name
- System, Documentation, Breast Lesion
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3010914393
- 3020798169
- 3013951855
Source Documents#
510(k) summary PDF not indicated by FDA