510(k) K014300
K014300 is an FDA 510(k) premarket notification submitted by James D Rusin MD, MBA for the device "SAFETOUCH". The FDA issued a decision of Substantially Equivalent on March 1, 2002. The device falls under product code NHM (Sheet, Recording, Breast Examination), a Class II device regulated under 21 CFR 884.2990.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2002
- Date Received
- December 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sheet, Recording, Breast Examination
- Device Class
- Class II
- Regulation Number
- 884.2990
- Review Panel
- OB
- Submission Type
This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.