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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 K033317
Device Name SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
Applicant
Opus Medical, Inc.
27127 Calle Arroyo, Suite 1924
San Juan Capistrano,  CA  92675
Applicant Contact LAURA N KASPEROWICZ
Correspondent
Opus Medical, Inc.
27127 Calle Arroyo, Suite 1924
San Juan Capistrano,  CA  92675
Correspondent Contact LAURA N KASPEROWICZ
Regulation Number876.1500
Classification Product Code
OCW  
Date Received10/15/2003
Decision Date 12/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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