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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Surgical, Gynecological
510(k) Number K134047
Device Name JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
Applicant
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Applicant Contact RUTHANNE VENDY
Correspondent
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Correspondent Contact RUTHANNE VENDY
Regulation Number884.4530
Classification Product Code
HCZ  
Date Received12/31/2013
Decision Date 04/11/2014
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
Predetermined Change
Control Plan Authorized		 No
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