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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K073369
Device Name EI DOWNPAK BARRIER SLEEVES
Applicant
Hu-Friedy Mfg. Co., Inc.
3232 N Rockwell St.
Chicago,  IL  60618
Applicant Contact KEITH DUNN
Correspondent
Hu-Friedy Mfg. Co., Inc.
3232 N Rockwell St.
Chicago,  IL  60618
Correspondent Contact KEITH DUNN
Regulation Number872.3850
Classification Product Code
EKM  
Date Received11/30/2007
Decision Date 02/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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