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.
| 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 |