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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 K971588
Device Name EVI SUTURED-CLIP APPLIER
Applicant
ELECTIVE VASCULAR INTERVENTION INC. (EVI)
2108 BLACKWOOD DR.
WALNUT CREEK,  CA  94596
Applicant Contact MICHAEL A DANIEL
Correspondent
ELECTIVE VASCULAR INTERVENTION INC. (EVI)
2108 BLACKWOOD DR.
WALNUT CREEK,  CA  94596
Correspondent Contact MICHAEL A DANIEL
Regulation Number878.4300
Classification Product Code
FZP  
Date Received05/01/1997
Decision Date 10/24/1997
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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