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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K003169
Device Name VASCULAR CLOSURE DEVICE
Applicant
STD MFG., INC.
1063 TURNPIKE ST.
P.O. BOX 420
STOUGHTON,  MA  02072
Applicant Contact STEPHEN M PALUMBO
Correspondent
STD MFG., INC.
1063 TURNPIKE ST.
P.O. BOX 420
STOUGHTON,  MA  02072
Correspondent Contact STEPHEN M PALUMBO
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/10/2000
Decision Date 12/08/2000
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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