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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 K141625
Device Name POLYSYN SURGICAL SUTURE
Applicant
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Applicant Contact PAUL AMUDALA
Correspondent
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Correspondent Contact PAUL AMUDALA
Regulation Number878.4493
Classification Product Code
GAM  
Date Received06/17/2014
Decision Date 07/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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