FDA 510(k) Application Details - K992103

Device Classification Name

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510(K) Number K992103
Device Name C-QUEST
Applicant WUESTEC MEDICAL, INC.
5600 COMMERCE BLVD., EAST
MOBILE, AL 36619-0037 US
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Contact BRENDA DAVIS
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Regulation Number

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Classification Product Code OWB
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Date Received 06/22/1999
Decision Date 09/01/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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