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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cotton, Roll
510(k) Number K871464
Device Name MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER
Applicant
Medgroup Enterprises, Inc.
1201 S. Flower St.
Burbank,  CA  91502
Applicant Contact RAYMOND D CLARK
Correspondent
Medgroup Enterprises, Inc.
1201 S. Flower St.
Burbank,  CA  91502
Correspondent Contact RAYMOND D CLARK
Regulation Number872.6050
Classification Product Code
EFN  
Date Received04/14/1987
Decision Date 04/30/1987
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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