510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850207Substantially Equivalent

Penpoint, Flexible & Spot Markers & Radoactive Rul

Syncor Intl. Corp., Sylmar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850207 is the FDA 510(k) clearance record for PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL, cleared for Syncor Intl. Corp. on . FDA records list 31 510(k) clearances for Syncor Intl. Corp., from to . As of , FDA records show no recalls naming K850207.

Clearance record

Decision date
Received
(42 days to decision)
Review panel
Unknown
Applicant
Syncor Intl. Corp. 12847 Arroyo St., Sylmar CA
Third party review
No