FDA 510(k) Application Details - K963624

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K963624
Device Name Accelerator, Linear, Medical
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 892.5050

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Classification Product Code IYE
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Date Received 09/11/1996
Decision Date 12/06/1996
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



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