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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 K926033
Device Name VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
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 Received12/01/1992
Decision Date 05/05/1993
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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