510(k) K881371

COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE by Cox Sterile Products, Inc. — Product Code KMH

K881371 is an FDA 510(k) premarket notification submitted by Cox Sterile Products, Inc. for the device "COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Cox Sterile Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
April 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Dry Heat
Device Class
Class II
Regulation Number
880.6870
Review Panel
HO
Submission Type