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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ring, Teething, Fluid-Filled
510(k) Number K902974
Device Name COOLING TEETHERS
Applicant
Realgrow Intl. Corp.
441 W. Allen Ave.
Unit #102
San Dimas,  CA  91773
Applicant Contact CINDY LEUNG
Correspondent
Realgrow Intl. Corp.
441 W. Allen Ave.
Unit #102
San Dimas,  CA  91773
Correspondent Contact CINDY LEUNG
Regulation Number872.5550
Classification Product Code
KKO  
Date Received07/06/1990
Decision Date 04/03/1991
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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