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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 K861727
Device Name COTTON FILLED GAUZE SPONGES 2 X 2
Applicant
Cross Country Paper Products Corp.
P.O. Box 558
67 Newmans Court
Hempstead,  NY  11550
Applicant Contact ALAN P SCHWARTZ
Correspondent
Cross Country Paper Products Corp.
P.O. Box 558
67 Newmans Court
Hempstead,  NY  11550
Correspondent Contact ALAN P SCHWARTZ
Regulation Number872.6050
Classification Product Code
EFN  
Date Received05/06/1986
Decision Date 07/10/1986
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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