FDA 510(k) Application Details - K022411

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K022411
Device Name System,Planning,Radiation Therapy Treatment
Applicant PRECISION THERAPY INTL., INC.
3155 NORTHWOODS PKWY NW
NORCROSS, GA 30071 US
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Contact PETER STEGAGNO
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 07/24/2002
Decision Date 09/20/2002
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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