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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K920421
Device Name MEDSURG MARSHMALLOW TRAY
Applicant
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Applicant Contact THOMAS BONNER
Correspondent
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Correspondent Contact THOMAS BONNER
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
LRO  
Date Received01/31/1992
Decision Date 12/13/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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