FDA 510(k) Application Details - K013460

Device Classification Name Extractor, Vacuum, Fetal

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510(K) Number K013460
Device Name Extractor, Vacuum, Fetal
Applicant SWIFT DELIVERY PRODUCTS
6824 ELK CANYON RD.
OKLAHOMA CITY, OK 73162 US
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Contact RICHARD G LINDSAY
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Regulation Number 884.4340

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Classification Product Code HDB
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Date Received 10/18/2001
Decision Date 01/17/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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