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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K070783
Device Name SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
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 Number884.1730
Classification Product Code
HIF  
Date Received03/21/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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