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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 K971797
Device Name LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
Applicant
LOUISVILLE LABORATORIES, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
LOUISVILLE LABORATORIES, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
EZL  
Date Received05/15/1997
Decision Date 07/22/1997
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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