The following data is part of a premarket notification filed by Cr Bard with the FDA for Sitescrub Ipa Device.
Device ID | K112791 |
510k Number | K112791 |
Device Name: | SITESCRUB IPA DEVICE |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | CR BARD 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Contact | Lynn M Kirchoff |
Correspondent | Lynn M Kirchoff CR BARD 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Product Code | LKB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2011-09-26 |
Decision Date | 2012-02-24 |
Summary: | summary |