510(k) K823457

NON-PRESSURE AUTOCLAVE FOR STERILIZATION by Interdent, Inc. — Product Code FLE

K823457 is an FDA 510(k) premarket notification submitted by Interdent, Inc. for the device "NON-PRESSURE AUTOCLAVE FOR STERILIZATION". The FDA issued a decision of Substantially Equivalent on February 23, 1983. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Interdent, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1983
Date Received
November 18, 1982
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