510(k) K924380

MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE by Mdt Corp., Inc. — Product Code MLR

K924380 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE". The FDA issued a decision of Substantially Equivalent on February 16, 1994. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1994
Date Received
August 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type