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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K970282
Device Name MEDLINE CIRCUMCISION TRAY
Applicant
Medline
One Medline Place
Mundelein,  IL  60060
Correspondent
Medline
One Medline Place
Mundelein,  IL  60060
Regulation Number884.4530
Classification Product Code
HFX  
Date Received01/24/1997
Decision Date 03/06/1997
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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