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 | K151788 |
510k Number | K151788 |
Device Name: | Cardinal Health Sterilization Wrap |
Classification | Wrap, Sterilization |
Applicant | Cardinal Health 200, LLC 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
Contact | Megan Middaugh |
Correspondent | Megan Middaugh 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 | 2015-07-01 |
Decision Date | 2015-10-30 |
Summary: | summary |