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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K042048
Device Name GELATO PROPHYLAXIS PASTE
Applicant
Deepak Products, Inc.
5220 NW 72nd Ave., Bay 15
Miami,  FL  33166
Applicant Contact RICARDO A CARLES
Correspondent
Deepak Products, Inc.
5220 NW 72nd Ave., Bay 15
Miami,  FL  33166
Correspondent Contact RICARDO A CARLES
Regulation Number872.6030
Classification Product Code
EJR  
Date Received07/30/2004
Decision Date 10/26/2004
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
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