FDA 510(k) Application Details - K935998

Device Classification Name Wire, Guide, Catheter

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510(K) Number K935998
Device Name Wire, Guide, Catheter
Applicant CAMP INTL., INC.
P.O. BOX 352
GRAND RAPIDS, MI US
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Contact KATHLEEN P FOCHTMAN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 12/15/1993
Decision Date 11/17/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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