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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 K022384
Device Name XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
Applicant
ISOLUX AMERICA
1479 RAILHEAD BLVD.
NAPLES,  FL  34110 -8444
Applicant Contact NIKOLAOS ANDREOULAKIS
Correspondent
ISOLUX AMERICA
1479 RAILHEAD BLVD.
NAPLES,  FL  34110 -8444
Correspondent Contact NIKOLAOS ANDREOULAKIS
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/22/2002
Decision Date 10/18/2002
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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