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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K991490
Device Name ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
Applicant
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Applicant Contact MILDRED M GOLDSTEIN
Correspondent
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Correspondent Contact MILDRED M GOLDSTEIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/28/1999
Decision Date 07/15/1999
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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