The following data is part of a premarket notification filed by Medical Action Industries, Inc. with the FDA for Drape, Surgical, X-ray Element, Models Non Sterile 6120-00, Sterile 704-b, Non Sterile 6124-00x, Sterile 704-bx.
| Device ID | K042526 |
| 510k Number | K042526 |
| Device Name: | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX |
| Classification | Drape, Surgical |
| Applicant | MEDICAL ACTION INDUSTRIES, INC. 25 HEYWOOD RD. Arden, NC 28704 |
| Contact | Robin Blankenbaker |
| Correspondent | Robin Blankenbaker MEDICAL ACTION INDUSTRIES, INC. 25 HEYWOOD RD. Arden, NC 28704 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-17 |
| Decision Date | 2005-04-25 |