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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K992480
Device Name MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
Applicant
MEDIFIX, INC.
8727 NARRAGANSETT
MORTON GROVE,  IL  60053 -0000
Applicant Contact GEORGE ALBULESCU
Correspondent
MEDIFIX, INC.
8727 NARRAGANSETT
MORTON GROVE,  IL  60053 -0000
Correspondent Contact GEORGE ALBULESCU
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
GCJ  
Date Received07/26/1999
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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