510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K853428Substantially Equivalent

CPR Prompt

Hutchins Tool & Engineering Co., Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853428 is the FDA 510(k) clearance record for CPR PROMPT, cleared for Hutchins Tool & Engineering Co., Inc. on . FDA records list one 510(k) clearance for Hutchins Tool & Engineering Co., Inc. As of , FDA records show no recalls naming K853428.

Clearance record

Decision date
Received
(22 days to decision)
Review panel
Unknown
Applicant
Hutchins Tool & Engineering Co., Inc. Burditt, Bowles & Radzius, Washington DC
Third party review
No