The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Sterilization Wrap.
| Device ID | K161910 |
| 510k Number | K161910 |
| Device Name: | Cardinal Health Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | CARDINAL HEALTH 200, LLC 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Megan Middaugh |
| Correspondent | Tatyana Bogdan CARDINAL HEALTH 200, LLC 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-12 |
| Decision Date | 2017-04-20 |
| Summary: | summary |