INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,

Set, I.v. Fluid Transfer

CARMEL PHARMA AB.

The following data is part of a premarket notification filed by Carmel Pharma Ab. with the FDA for Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35c, Connector Luer Lock, Model C35,.

Pre-market Notification Details

• Device ID: K092782
• 510k Number: K092782
• Device Name: INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
• Classification: Set, I.v. Fluid Transfer
• Applicant: CARMEL PHARMA AB. AMINOGATAN 30 Molndal, SE S431 53
• Contact: Kjell Andreasson
• Correspondent: Kjell Andreasson; CARMEL PHARMA AB. AMINOGATAN 30 Molndal, SE S431 53
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-10
• Decision Date: 2009-12-07
• Summary: summary