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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 K062241
Device Name ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
Applicant
NORTH AMERICAN SCIENTIFIC, INC.
20200 SUNBURST ST.
CHATSWORTH,  CA  91311
Applicant Contact LEIGH SPOTTEN
Correspondent
NORTH AMERICAN SCIENTIFIC, INC.
20200 SUNBURST ST.
CHATSWORTH,  CA  91311
Correspondent Contact LEIGH SPOTTEN
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/02/2006
Decision Date 11/09/2006
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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