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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K091230
Device Name HDR PROSTATE TEMPLATE AND ACCESSORIES
Applicant
Photon Technologies Corporation
1572 N. Hwy. 85, Suite 308
Fayetteville,  GA  30214
Applicant Contact JEFFREY A EDWARDS
Correspondent
Photon Technologies Corporation
1572 N. Hwy. 85, Suite 308
Fayetteville,  GA  30214
Correspondent Contact JEFFREY A EDWARDS
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received04/27/2009
Decision Date 08/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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