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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K030292
Device Name GROMAN PREPMASTER
Applicant
Groman, Inc.
1917 NW 80 Ave.
Margate,  FL  33063
Applicant Contact BARRY B GROMAN
Correspondent
Groman, Inc.
1917 NW 80 Ave.
Margate,  FL  33063
Correspondent Contact BARRY B GROMAN
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received01/28/2003
Decision Date 04/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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