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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic tissue approximation device
510(k) Number K994087
Device Name SUPERSTITCH
Applicant
SUTURA, INC.
17080 NEWHOPE ST.
fountain valley,  CA  92708
Applicant Contact dave barry
Correspondent
SUTURA, INC.
17080 NEWHOPE ST.
fountain valley,  CA  92708
Correspondent Contact dave barry
Regulation Number876.1500
Classification Product Code
OCW  
Date Received12/03/1999
Decision Date 03/01/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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