FDA 510(k) Application Details - K992476

Device Classification Name Stabilizer,Heart

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510(K) Number K992476
Device Name Stabilizer,Heart
Applicant PILLING WECK SURGICAL
420 DELAWARE DR.
FORT WASHINGTON, PA 19034 US
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Contact RICHARD G JONES
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Regulation Number 870.4500

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Classification Product Code MWS
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Date Received 07/26/1999
Decision Date 09/13/2000
Decision SESE - SUBST EQUIV
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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