FDA 510(k) Application Details - K972966

Device Classification Name Collimator, Manual, Radiographic

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510(K) Number K972966
Device Name Collimator, Manual, Radiographic
Applicant APPLIED X-RAY TECHNOLOGIES, INC.
2727 WEST 92ND AVE.,
SUITE 10
DENVER, CO 80221 US
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Contact HOWARD C THOMAS
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Regulation Number 892.1610

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Classification Product Code IZX
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Date Received 08/11/1997
Decision Date 08/21/1997
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

FDA Source Information for K972966


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