APD LUER-LOCK ADAPTER

Set, Administration, For Peritoneal Dialysis, Disposable

FRESENSIUS MEDICAL CARE NORTH AMERICA

The following data is part of a premarket notification filed by Fresensius Medical Care North America with the FDA for Apd Luer-lock Adapter.

Pre-market Notification Details

• Device ID: K124024
• 510k Number: K124024
• Device Name: APD LUER-LOCK ADAPTER
• Classification: Set, Administration, For Peritoneal Dialysis, Disposable
• Applicant: FRESENSIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST Waltham, MA 02451
• Contact: Denise Oppermann
• Correspondent: Denise Oppermann; FRESENSIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST Waltham, MA 02451
• Product Code: KDJ
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-28
• Decision Date: 2013-09-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840861100818	K124024	000