510(k) K840536
K840536 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "CRYO SURG 5900". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Frigitronics of Connecticut, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1984
- Date Received
- February 8, 1984
- 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