510(k) K934261
K934261 is an FDA 510(k) premarket notification submitted by Erbe Elektromedizin GmbH for the device "ERBOKRYO CA CRYOSURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Erbe Elektromedizin GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1994
- Date Received
- August 31, 1993
- 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