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FDA 510(k) Application Details - K972112
Device Classification Name
Catheter, Peritoneal
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510(K) Number
K972112
Device Name
Catheter, Peritoneal
Applicant
TAUT, INC.
2571 KANEVILLE COURT
P.O. BOX 326
GENEVA, IL 60134 US
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Contact
GLENN MILLER
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Regulation Number
878.4200
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Classification Product Code
GBW
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More FDA Info for this Product Code
Date Received
06/05/1997
Decision Date
12/01/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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