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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 K872810
Device Name STRUNG DENTAL ROLLS
Applicant
American Silk Sutures, Inc.
57 Munroe St.
Lynn,  MA  01901
Applicant Contact ED GREENSPAN
Correspondent
American Silk Sutures, Inc.
57 Munroe St.
Lynn,  MA  01901
Correspondent Contact ED GREENSPAN
Regulation Number872.6050
Classification Product Code
EFN  
Date Received07/14/1987
Decision Date 12/04/1987
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
Recalls CDRH Recalls
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