510(k) K072414
K072414 is an FDA 510(k) premarket notification submitted by Lil Drug Store Products, Inc. for the device "CRYOSTAT". The FDA issued a decision of Substantially Equivalent on Apr 7, 2008. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. Lil Drug Store Products, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2008
- Date Received
- Aug 28, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Thermal, Hemorrhoids
- Device Class
- Class U
- Review Panel
- GU
- Submission Type
- 510(k)