510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K837352Substantially Equivalent

Ceilex Ls-15/Allmec Argostat

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837352 is the FDA 510(k) clearance record for CEILEX LS-15/ALLMEC ARGOSTAT, cleared for Elscint, Inc. on . FDA records list 94 510(k) clearances for Elscint, Inc., from to . As of , FDA records show no recalls naming K837352.

Clearance record

Decision date
Received
(9 days to decision)
Review panel
Unknown
Applicant
Elscint, Inc. 505 Main St., Hackensack NJ
Third party review
No