FDA 510(k) Application Details - K041018

Device Classification Name Spatula, Cervical, Cytological

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510(K) Number K041018
Device Name Spatula, Cervical, Cytological
Applicant DOCTOR'S RESEARCH GROUP, INC.
50 ALTAIR AVE.
PLYMOUTH, CT 06782 US
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Contact EDWARD H GOLDMAN
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Regulation Number 884.4530

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Classification Product Code HHT
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Date Received 04/20/2004
Decision Date 10/18/2004
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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