510(k) K901146

JOSLYN EO STERILIZER/ EO MODERNIZATION KIT by Joslyn Valve Corp. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1991
Date Received
March 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type