510(k) K895848

PRESSURE STEAM STERILIZERS by Scientific Device Laboratory, Inc. — Product Code FLE

K895848 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "PRESSURE STEAM STERILIZERS". The FDA issued a decision of Substantially Equivalent on December 11, 1989. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1989
Date Received
October 3, 1989
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