510(k) K040529

COCOON HYGIENIST by Satelec — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2004
Date Received
March 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type