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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 K012865
Device Name SUPERSTITCH VASCULAR SUTURING DEVICE
Applicant
SUTURA, INC.
17080 NEWHOPE ST.
FOUNTAIN VALLEY,  CA  92708
Applicant Contact JAMES BONDS
Correspondent
SUTURA, INC.
17080 NEWHOPE ST.
FOUNTAIN VALLEY,  CA  92708
Correspondent Contact JAMES BONDS
Regulation Number878.5010
Classification Product Code
GAW  
Date Received08/27/2001
Decision Date 09/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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