510(k) K984380
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