The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Bioshield Express Sterilization Wrap.
| Device ID | K983719 |
| 510k Number | K983719 |
| Device Name: | BIOSHIELD EXPRESS STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Patricia Sharpe-gregg |
| Correspondent | Patricia Sharpe-gregg 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 | 1998-10-21 |
| Decision Date | 1999-08-25 |
| Summary: | summary |