GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM

Wrap, Sterilization

ALLEGIANCE HEALTHCARE CORP.

The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Genesis Sterrad Compatible Reusable Sterilization Container System.

Pre-market Notification Details

• Device ID: K012931
• 510k Number: K012931
• Device Name: GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
• Classification: Wrap, Sterilization
• Applicant: ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085
• Contact: Lance Marconi
• Correspondent: Lance Marconi; ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-31
• Decision Date: 2002-08-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885403122927	K012931	000
10885403037252	K012931	000
10885403108143	K012931	000
10885403418044	K012931	000
10885403418037	K012931	000
10885403418020	K012931	000
10885403418013	K012931	000
20885403159937	K012931	000
20885403056670	K012931	000