The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Convertors Impervious Shoe Covers.
| Device ID | K970815 |
| 510k Number | K970815 |
| Device Name: | CONVERTORS IMPERVIOUS SHOE COVERS |
| Classification | Cover, Shoe, Operating-room |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-06 |
| Decision Date | 1997-03-27 |
| Summary: | summary |