510(k) K852113

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 by Ars Enterprises, Inc. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1985
Date Received
May 15, 1985
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