510(k) K992286
K992286 is an FDA 510(k) premarket notification submitted by Rhealm Pharmaceuticals, Inc. for the device "DERMAFREEZE". The FDA issued a decision of Substantially Equivalent on January 21, 2000. The device falls under product code MLY (Vapocoolant Device), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2000
- Date Received
- July 7, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vapocoolant Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type