FDA 510(k) Application Details - K881306

Device Classification Name Extractor, Vacuum, Fetal

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510(K) Number K881306
Device Name Extractor, Vacuum, Fetal
Applicant CHALLENGE MFG., INC.
P.O. BOX 5877
BEND, OR US
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Contact EMILY SMITH
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Regulation Number 884.4340

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Classification Product Code HDB
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Date Received 03/28/1988
Decision Date 06/13/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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