The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Convertors Safecare Gown & Drape Material.
| Device ID | K913506 |
| 510k Number | K913506 |
| Device Name: | CONVERTORS SAFECARE GOWN & DRAPE MATERIAL |
| Classification | Drape, Surgical |
| Applicant | BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. Mcgaw Pk, IL 60085 |
| Contact | Henry Bodner |
| Correspondent | Henry Bodner BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. Mcgaw Pk, IL 60085 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1991-10-11 |