Cleared Traditional

GROMAN PREPMASTER

K030292 · Groman, Inc. · Dental

Apr 2003

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K030292 is an FDA 510(k) clearance for the GROMAN PREPMASTER, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Groman, Inc. (Margate, US). The FDA issued a Cleared decision on April 15, 2003, 77 days after receiving the submission on January 28, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number	K030292 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2003
Decision Date	April 15, 2003
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement