MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET

Set, Administration, Intravascular

P/L Biomedical

The following data is part of a premarket notification filed by P/l Biomedical with the FDA for Maersk Medical Pureline Comfort Subcutaneous Infusion Set.

Pre-market Notification Details

• Device ID: K972135
• 510k Number: K972135
• Device Name: MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
• Classification: Set, Administration, Intravascular
• Applicant: P/L Biomedical 7690 CAMERON CIRCLE Fort Myers, FL 33912
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-06
• Decision Date: 1997-08-26
• Summary: summary