FDA 510(k) Application Details - K973494

Device Classification Name Wire, Guide, Catheter

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510(K) Number K973494
Device Name Wire, Guide, Catheter
Applicant GUIDANT CORP.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA, CA 95052-8167 US
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Contact MARGARET ANDERSON
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 09/15/1997
Decision Date 12/12/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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