510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811114Substantially Equivalent

Model P-8 Professional

Bloomex International, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811114 is the FDA 510(k) clearance record for MODEL P-8 PROFESSIONAL, cleared for Bloomex International, Inc. on . FDA records list 16 510(k) clearances for Bloomex International, Inc., from to . As of , FDA records show no recalls naming K811114.

Clearance record

Decision date
Received
(214 days to decision)
Review panel
Unknown
Applicant
Bloomex International, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No