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510(k) Data Aggregation

K Number

Device Name

SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE

Manufacturer

TERUMO MEDICAL CORP.

Date Cleared

2001-02-12

(84 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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