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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 K072912
Device Name SOPRO 225 DUAL HALOGEN LIGHT SOURCE
Applicant
SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Applicant Contact STEVE SALESKY
Correspondent
SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Correspondent Contact STEVE SALESKY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/12/2007
Decision Date 11/16/2007
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
Predetermined Change
Control Plan Authorized		 No
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