KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600

Wrap, Sterilization

KIMBERLY-CLARK CORP.

The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimguard Sterilization Wrap, Models Kc100, Kc200, Kc300, Kc400, Kc500 And Kc600.

Pre-market Notification Details

• Device ID: K082554
• 510k Number: K082554
• Device Name: KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
• Classification: Wrap, Sterilization
• Applicant: KIMBERLY-CLARK CORP. 172 CONDUCTOR DRIVE Dawsonville, GA 30534
• Contact: Lisa Peacock
• Correspondent: Lisa Peacock; KIMBERLY-CLARK CORP. 172 CONDUCTOR DRIVE Dawsonville, GA 30534
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-03
• Decision Date: 2009-05-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30680651780363	K082554	000
30680651780240	K082554	000