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FDA 510(k) Application Details - K973485
Device Classification Name
Lavage, Jet
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510(K) Number
K973485
Device Name
Lavage, Jet
Applicant
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS, MI 49501 US
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Contact
GRETCHEN HARTLAGE
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Regulation Number
880.5475
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Classification Product Code
FQH
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More FDA Info for this Product Code
Date Received
09/15/1997
Decision Date
12/08/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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