FDA 510(k) Application Details - K955519

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K955519
Device Name System, X-Ray, Angiographic
Applicant CAMTRONICS, LTD.
900 WALNUT RIDGE DR.
P.O. BOX 950
HARTLAND, WI 53029 US
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Contact ROBERT KRIEDERMANN
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 12/04/1995
Decision Date 05/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K955519


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