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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K082796
Device Name SOPRO 184 CAMERA
Applicant
SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Correspondent Contact RICK ROSATI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/23/2008
Decision Date 04/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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