510(k) K882568
K882568 is an FDA 510(k) premarket notification submitted by Spembly Medical , Ltd. for the device "130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY". The FDA issued a decision of Substantially Equivalent on September 27, 1988. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Spembly Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1988
- Date Received
- June 22, 1988
- 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