510(k) K023390
- Device
- MY BREAST FRIEND, BREAST SELF-EXAM PAD
- Applicant
- MBF SALES, LLC
- 510(k) number
- K023390
- Product code
- IXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-26
- Date received
- 2002-10-09
- Regulation
- 892.1940
- Classification name
- Camera, Focal Spot, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDUARDO MARCH
- Address
- 7361 Calhoun Pl., Suite 500 Rockville MD US 20855 20855
FDA Registration Numbers#
- 3009973336
- 3008788412
Source Documents#
Other 510(k) Records For Product Code IXH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851811 | SLIT CAMERA MODEL 07-624 | Victoreen, Inc. | 1985-05-28 |
Legacy Summary#
summary
FDA Review#
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