510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860022Substantially Equivalent

Paragon Micro-Loops

Paragon Medical and Scientific, Inc., Saint Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860022 is the FDA 510(k) clearance record for PARAGON MICRO-LOOPS, cleared for Paragon Medical and Scientific, Inc. on . FDA records list one 510(k) clearance for Paragon Medical and Scientific, Inc. As of , FDA records show no recalls naming K860022.

Clearance record

Decision date
Received
(80 days to decision)
Review panel
Unknown
Applicant
Paragon Medical and Scientific, Inc. 328 State St., Saint Paul MN
Third party review
No