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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 K140227
Device Name MONODERM SURGICAL SUTURE
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Applicant Contact KIRSTEN STOWELL FRANCO
Correspondent
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Correspondent Contact KIRSTEN STOWELL FRANCO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received01/30/2014
Decision Date 02/28/2014
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
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