The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Durablue Sterilization Wrap, Model Numbers Ch100, Ch200, Ch300, Ch400, Ch500 And Ch600, Sterrad Nx Sterilization.
| Device ID | K122507 |
| 510k Number | K122507 |
| Device Name: | DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION |
| Classification | Wrap, Sterilization |
| Applicant | CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2012-09-26 |
| Summary: | summary |