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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 K771938
Device Name ALGINATE IMPRESSION MATERIAL
Applicant
The S. S. White Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The S. S. White Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/17/1977
Decision Date 11/02/1977
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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