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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K994353
Device Name SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
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 Number884.2720
Classification Product Code
HFM  
Date Received12/23/1999
Decision Date 03/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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