510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864923Substantially Equivalent

Vacu-Prep

Diversified High Tech Co., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864923 is the FDA 510(k) clearance record for VACU-PREP, cleared for Diversified High Tech Co. on . FDA records list one 510(k) clearance for Diversified High Tech Co. As of , FDA records show no recalls naming K864923.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Diversified High Tech Co. Kleinfeld, Kaplan & Becker, Washington DC
Third party review
No