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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, Polyethylene
510(k) Number K042031
Device Name OPUS SPEEDSTITCH SUTURE DEVICE
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 Number878.5000
Classification Product Code
GAT  
Date Received07/28/2004
Decision Date 10/19/2004
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
Recalls CDRH Recalls
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