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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K050180
Device Name EXPA-SYL
Applicant
Produits Dentaires Pierre Rolland
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
Produits Dentaires Pierre Rolland
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Classification Product Code
MVL  
Date Received01/26/2005
Decision Date 02/11/2005
Decision Substantially Equivalent (SESE)
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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