FDA 510(k) Application Details - K971849

Device Classification Name Spatula, Cervical, Cytological

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510(K) Number K971849
Device Name Spatula, Cervical, Cytological
Applicant TEAM TECHNOLOGIES, INC.
5949 COMMERCE BLVD.
MORRISTOWN, TN 37814 US
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Contact BOB WALTON
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Regulation Number 884.4530

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Classification Product Code HHT
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Date Received 05/19/1997
Decision Date 07/24/1997
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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