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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorber, Saliva, Paper
510(k) Number K891054
Device Name NON-STERILE GAUZE SPONGE
Applicant
DISPOMED, INC.
1201 SOUTH FLOWER ST.
BURBANK,  CA  91520
Applicant Contact KENT BRANIFF
Correspondent
DISPOMED, INC.
1201 SOUTH FLOWER ST.
BURBANK,  CA  91520
Correspondent Contact KENT BRANIFF
Regulation Number872.6050
Classification Product Code
KHR  
Date Received02/27/1989
Decision Date 05/01/1989
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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