The following data is part of a premarket notification filed by Kimberly-clark Health Care with the FDA for Kimguard One-step Sterilization Wrap.
Device ID | K143053 |
510k Number | K143053 |
Device Name: | KIMGUARD ONE-STEP Sterilization Wrap |
Classification | Wrap, Sterilization |
Applicant | KIMBERLY-CLARK HEALTH CARE 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
Contact | Monica King |
Correspondent | Monica King KIMBERLY-CLARK HEALTH CARE 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-23 |
Decision Date | 2015-04-03 |
Summary: | summary |