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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K123940
Device Name DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
Applicant
Demetech Corp.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact JOHN O'BRIEN
Correspondent
Demetech Corp.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact JOHN O'BRIEN
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/20/2012
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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