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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K974297
Device Name GALILEO DISPOSABLE HYSTEROSCOPES
Applicant
NETOPTIX CORP.
49 PLAIN ST.
NORTH ATTLEBORO,,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
NETOPTIX CORP.
49 PLAIN ST.
NORTH ATTLEBORO,,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number884.1690
Classification Product Code
HIH  
Date Received11/17/1997
Decision Date 02/13/1998
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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