510(k) K832140

CRYOMEDICS 5000 CRYOPROBES by Spembly Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 28, 1983
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