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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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More FDA Info for this Product Code
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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