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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 K180625
Device Name Rondek PGA Suture (Beige or Violet)
Applicant
Rk Manufacturing Corporation
34 Executive Dr.
Danbury,  CT  06810
Applicant Contact Joshua Hubbard
Correspondent
Clover Medical, LLC
79 Haven St.
Dover,  MA  02030
Correspondent Contact John Gillespie
Regulation Number878.4493
Classification Product Code
GAM  
Date Received03/09/2018
Decision Date 05/10/2018
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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