FDA 510(k) Application Details - K990423

Device Classification Name Collimator, Automatic, Radiographic

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510(K) Number K990423
Device Name Collimator, Automatic, Radiographic
Applicant PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON, CT 06484 US
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Contact PETER ALTMAN
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Regulation Number 892.1610

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Classification Product Code IZW
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Date Received 02/11/1999
Decision Date 03/15/1999
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



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