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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 K840127
Device Name CURIETRON
Applicant
Syncor Intl. Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Syncor Intl. Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received01/11/1984
Decision Date 03/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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