FDA 510(k) Application Details - K992603

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

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510(K) Number K992603
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant WUESTEC MEDICAL, INC.
5600 COMMERCE BLVD., EAST
MOBILE, AL 36619-0037 US
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Contact BRENDA S DAVIS
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Regulation Number 892.1650

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Classification Product Code JAA
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Date Received 08/03/1999
Decision Date 10/25/1999
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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