510(k) K021613

NIVEOUS LIQUID DAM by Shofu Dental Corp. — Product Code EIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2002
Date Received
May 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type