FDA 510(k) Application Details - K980379

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K980379
Device Name Accelerator, Linear, Medical
Applicant SSGI PROWESS SYSTEMS
1370 RIDGEWOOD DR., #20
CHICO, CA 95973-7803 US
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Contact THOMAS A BOONE
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 01/30/1998
Decision Date 05/18/1998
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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