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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K895889
Device Name SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
Applicant
Leach and Dillon Co., Inc.
171 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact CHERI KRATZ
Correspondent
Leach and Dillon Co., Inc.
171 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact CHERI KRATZ
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/05/1989
Decision Date 04/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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