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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ

Manufacturer

Date Cleared

2000-08-24

(76 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K052996,K081171

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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