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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, removable (skin)
510(k) Number K844837
Device Name VISISTAT SKIN STAPLING DEVICE
Applicant
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Applicant Contact JEFFREY GREEN
Correspondent
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Correspondent Contact JEFFREY GREEN
Regulation Number878.4760
Classification Product Code
GDT  
Date Received12/12/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
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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