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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 K070352
Device Name MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
Applicant
MINI LAP TECHNOLOGIES INC.
543 LONG HILL AVE.
SHELTON,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
MINI LAP TECHNOLOGIES INC.
543 LONG HILL AVE.
SHELTON,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number876.1500
Classification Product Code
OCW  
Date Received02/06/2007
Decision Date 04/05/2007
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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