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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850207
Device Name PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
Applicant
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Correspondent Contact ELEANOR V CHIU
Date Received01/18/1985
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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