510(k) K934261

ERBOKRYO CA CRYOSURGICAL SYSTEM by Erbe Elektromedizin GmbH — Product Code GEH

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