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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 K884356
Device Name NORITAKE SUPER PORCELAIN EX-3
Applicant
Noritake Co., Inc.
75 Seaview Dr.
Secaucus,  NJ  07094
Applicant Contact HIROYASU HIROZAWA
Correspondent
Noritake Co., Inc.
75 Seaview Dr.
Secaucus,  NJ  07094
Correspondent Contact HIROYASU HIROZAWA
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/17/1988
Decision Date 01/10/1989
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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