The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Gemini Bonded Sterilization Wrap.
| Device ID | K143147 |
| 510k Number | K143147 |
| Device Name: | Gemini Bonded Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-05-07 |
| Summary: | summary |