510(k) K001716

REDON SET by Pfm Produkte Fur Die Medizin AG — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2000
Date Received
June 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type