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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K033161
Device Name VISU-LOCK 5MM CLIP APPLIER
Applicant
GYRX, LLC
11222 ST. JOHNS INDUSTRIAL
PARKWAY N.
JACKSONVILLE,  FL  32246
Applicant Contact CORY EDWARDS
Correspondent
GYRX, LLC
11222 ST. JOHNS INDUSTRIAL
PARKWAY N.
JACKSONVILLE,  FL  32246
Correspondent Contact CORY EDWARDS
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/30/2003
Decision Date 12/18/2003
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
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