510(k) K031574
K031574 is an FDA 510(k) premarket notification submitted by S & S X-Ray Products, Inc. for the device "SQUEEZE-EASE MAMMOGRAPHY CUSHION". The FDA issued a decision of Substantially Equivalent on Aug 4, 2003. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. S & S X-Ray Products, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 2003
- Date Received
- May 20, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1710
- Review Panel
- RA
- Submission Type
- 510(k)