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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Umbilical
510(k) Number K012917
Device Name DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
Applicant
Dynarex Corp.
7736 Woodside Ct.
Maineville,  OH  45039
Applicant Contact JOHN GAGLIARDI
Correspondent
Dynarex Corp.
7736 Woodside Ct.
Maineville,  OH  45039
Correspondent Contact JOHN GAGLIARDI
Regulation Number884.4530
Classification Product Code
HFW  
Date Received08/30/2001
Decision Date 11/28/2001
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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