510(k) K921885

E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES by Valleylab, Inc. — Product Code HGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1994
Date Received
April 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Perineal, Direct Contact
Device Class
Class II
Regulation Number
884.5390
Review Panel
OB
Submission Type