FDA 510(k) Application Details - K974310

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K974310
Device Name Accelerator, Linear, Medical
Applicant NOMOS CORP.
2591 WEXFORD BAYNE RD.
SUITE 400
SEWICKLEY, PA 15143 US
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Contact MARVIN L SUSSMAN
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 11/17/1997
Decision Date 02/06/1998
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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