510(k) K901147

JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT by Joslyn Valve Corp. — Product Code FLE

K901147 is an FDA 510(k) premarket notification submitted by Joslyn Valve Corp. for the device "JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT". The FDA issued a decision of Substantially Equivalent on November 30, 1990. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Joslyn Valve Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1990
Date Received
March 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type