510(k) K984380

DISPO ETCH by Kis Products — Product Code KOJ

K984380 is an FDA 510(k) premarket notification submitted by Kis Products for the device "DISPO ETCH". The FDA issued a decision of Substantially Equivalent on August 6, 2001. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Kis Products has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2001
Date Received
December 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type