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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 K001703
Device Name PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
Applicant
ABBOTT VASCULAR INC.
400 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact DENISE C SUNGLETON
Correspondent
ABBOTT VASCULAR INC.
400 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact DENISE C SUNGLETON
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Codes
GAB   HCF  
Date Received06/05/2000
Decision Date 10/03/2000
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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