510(k) K961714

ASEPTYLUM, UNI-CARRIER by Distriflor S.A. — Product Code EKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1996
Date Received
May 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type