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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 K994263
Device Name SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
Applicant
Precision Dynamics Corp.
13880 Del Sur St.
San Fernando,  CA  91340
Applicant Contact KALYNA SNYLYK
Correspondent
Precision Dynamics Corp.
13880 Del Sur St.
San Fernando,  CA  91340
Correspondent Contact KALYNA SNYLYK
Regulation Number884.4530
Classification Product Code
HFW  
Date Received12/17/1999
Decision Date 01/24/2000
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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