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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K864623
Device Name OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
Applicant
Xanmed Corp.
85v. Hoffman Ln.
Central Islip,  NY  11722
Applicant Contact PATRICIA CLANCY
Correspondent
Xanmed Corp.
85v. Hoffman Ln.
Central Islip,  NY  11722
Correspondent Contact PATRICIA CLANCY
Regulation Number884.4530
Classification Product Code
KNA  
Date Received11/25/1986
Decision Date 01/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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