FDA 510(k) Application Details - K961934

Device Classification Name Spatula, Cervical, Cytological

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510(K) Number K961934
Device Name Spatula, Cervical, Cytological
Applicant HARDWOOD PRODUCTS CO., LP
P.O. BOX 149, 31 SCHOOL ST.
GUILFORD, ME 04443 US
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Contact WILLIAM M YOUNG
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Regulation Number 884.4530

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Classification Product Code HHT
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Date Received 05/17/1996
Decision Date 07/09/1996
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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