The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterilization Wrap.
| Device ID | K002968 |
| 510k Number | K002968 |
| Device Name: | MEDLINE STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2001-01-23 |