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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 K052437
Device Name MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
Applicant
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Applicant Contact ELIZABETH LAZARO
Correspondent
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Correspondent Contact ELIZABETH LAZARO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/06/2005
Decision Date 11/07/2005
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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