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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 K122563
Device Name MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
Applicant
Hologic, Inc.
250 Campus Dr.
Marlborough,  MA  01752
Applicant Contact SARAH FAIRFIELD
Correspondent
Hologic, Inc.
250 Campus Dr.
Marlborough,  MA  01752
Correspondent Contact SARAH FAIRFIELD
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/22/2012
Decision Date 09/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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