510(k) K964047
K964047 is an FDA 510(k) premarket notification submitted by Biodermis Corp. for the device "CRYOSIL SILICONE GEL SHEETING". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Biodermis Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1997
- Date Received
- October 9, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type