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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, polypropylene
510(k) Number K070243
Device Name SUTRALENE POLYPROPYLENE SUTURES
Applicant
VISIONARY MEDICAL SUPPLIES, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
VISIONARY MEDICAL SUPPLIES, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number878.5010
Classification Product Code
GAW  
Date Received01/25/2007
Decision Date 04/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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