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510(k) K030292

GROMAN PREPMASTER by Groman, Inc. — Product Code KOJ

K030292 is an FDA 510(k) premarket notification submitted by Groman, Inc. for the device "GROMAN PREPMASTER". The FDA issued a decision of Substantially Equivalent on April 15, 2003. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2003
Date Received
January 28, 2003
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

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)

FDA data resources