The following data is part of a premarket notification filed by Allegiance Healthcare Coporation with the FDA for Surgical Drapes.
| Device ID | K002419 |
| 510k Number | K002419 |
| Device Name: | SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | ALLEGIANCE HEALTHCARE COPORATION 1500 WAUKERGAN RD. Mcgaw Park, IL 60085 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE COPORATION 1500 WAUKERGAN RD. Mcgaw Park, IL 60085 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-08-15 |