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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 K953812
Device Name GAUZE SPONGE
Applicant
Remington Medical, Inc.
8601 Dunwoody Pl., Suite 510
Atlanta,  GA  30350
Applicant Contact DON ROSVOLD
Correspondent
Remington Medical, Inc.
8601 Dunwoody Pl., Suite 510
Atlanta,  GA  30350
Correspondent Contact DON ROSVOLD
Regulation Number872.6050
Classification Product Code
KHR  
Date Received08/02/1995
Decision Date 10/02/1995
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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