510(k) K992553

IQ CHAMBERS by Dormer Laboratories, Inc. — Product Code KXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2000
Date Received
July 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type