FDA 510(k) Application Details - K994367

Device Classification Name Clamp, Umbilical

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510(K) Number K994367
Device Name Clamp, Umbilical
Applicant MEDICAL SALES CO.
P.O. BOX 540314
101 N. 700 WEST
NORTH SALT LAKE, UT 84054 US
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Contact JOHN E LINCOLN
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Regulation Number 884.4530

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Classification Product Code HFW
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Date Received 12/27/1999
Decision Date 03/17/2000
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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