The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Durablue Sterilization Wrap.
| Device ID | K130927 |
| 510k Number | K130927 |
| Device Name: | DURABLUE STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-03 |
| Decision Date | 2013-06-18 |
| Summary: | summary |