The following data is part of a premarket notification filed by Cardinal Health-medical Products And Services with the FDA for Durablue Sterilization Wrap.
| Device ID | K123289 |
| 510k Number | K123289 |
| Device Name: | DURABLUE STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Lavenia Ford |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2013-02-28 |
| Summary: | summary |