The following data is part of a premarket notification filed by Becton Dickinson And Co. with the FDA for Bd Visidrape Ophthalmic Drapes; Bd Visiflex Incise Drape.
| Device ID | K010572 |
| 510k Number | K010572 |
| Device Name: | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE |
| Classification | Drape, Surgical |
| Applicant | BECTON DICKINSON AND CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3212 |
| Contact | James Staffiera |
| Correspondent | James Staffiera BECTON DICKINSON AND CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3212 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-03-12 |