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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K022411
Device Name PRECISEPLAN 2.0
Applicant
PRECISION THERAPY INTL., INC.
3155 NORTHWOODS PKWY NW
NORCROSS,  GA  30071
Applicant Contact PETER STEGAGNO
Correspondent
PRECISION THERAPY INTL., INC.
3155 NORTHWOODS PKWY NW
NORCROSS,  GA  30071
Correspondent Contact PETER STEGAGNO
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/24/2002
Decision Date 09/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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