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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Film, X-Ray
510(k) Number K852170
Device Name EZX YELLOW, BLUE OR ORANGE
Applicant
Strong Marketing
Bs Ms
East 3730 Zeus
Mead,  WA  99021
Applicant Contact STRONG GRAINGE
Correspondent
Strong Marketing
Bs Ms
East 3730 Zeus
Mead,  WA  99021
Correspondent Contact STRONG GRAINGE
Regulation Number872.1905
Classification Product Code
EGZ  
Date Received05/20/1985
Decision Date 09/05/1985
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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