510(k) K112300

KIMGUARD SMART-FOLD* STERILIZATION WRAP by Kimberly-Clark Corp. — Product Code FRG

K112300 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMGUARD SMART-FOLD* STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on January 19, 2012. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2012
Date Received
August 10, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type