FDA 510(k) Application Details - K990737

Device Classification Name Clamp, Umbilical

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510(K) Number K990737
Device Name Clamp, Umbilical
Applicant PRECISION DYNAMICS CORP.
13880 DEL SUR ST.
SAN FERNANDO, CA 91340-3490 US
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Contact KALYNA SNYLYK
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Regulation Number 884.4530

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Classification Product Code HFW
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Date Received 03/05/1999
Decision Date 04/06/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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