The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Disposable Surgical Gowns.
| Device ID | K062969 |
| 510k Number | K062969 |
| Device Name: | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PL. Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PL. Mundelein, IL 60060 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2006-12-14 |