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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K050658
Device Name RESO-PAC PERIODONTAL DRESSING
Applicant
Hager Worldwide, Inc.
2000 M St., NW 7th Floor
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Hager Worldwide, Inc.
2000 M St., NW 7th Floor
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/14/2005
Decision Date 05/27/2005
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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