PHASEAL

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 Phaseal.

Pre-market Notification Details

• Device ID: K023747
• 510k Number: K023747
• Device Name: PHASEAL
• Classification: Set, I.v. Fluid Transfer
• Applicant: CARMEL PHARMA AB. BOX 5352 Gothenburg, SE 40228
• Contact: Kjell Andreasson
• Correspondent: Kjell Andreasson; CARMEL PHARMA AB. BOX 5352 Gothenburg, SE 40228
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-08
• Decision Date: 2002-11-15
• Summary: summary