510(k) K022861
- Device
- SAFETOUCH
- Applicant
- Rusin Medical Devices
- 510(k) number
- K022861
- Product code
- NHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-26
- Date received
- 2002-08-28
- Regulation
- 884.2990
- Classification name
- Sheet, Recording, Breast Examination
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- JAMES D RUSIN
- Address
- 3512 Rum River Dr. Anoka MN US 55303 55303
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NHM
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K014300 | SAFETOUCH | James D Rusin MD, MBA | 2002-03-01 |