TAKE 1

Material, Impression

KERR CORP.

The following data is part of a premarket notification filed by Kerr Corp. with the FDA for Take 1.

Pre-market Notification Details

• Device ID: K091613
• 510k Number: K091613
• Device Name: TAKE 1
• Classification: Material, Impression
• Applicant: KERR CORP. 1717 W. COLLINS AVENUE Orange, CA 92867
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; KERR CORP. 1717 W. COLLINS AVENUE Orange, CA 92867
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-03
• Decision Date: 2009-10-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841396118538	K091613	000
10841396118248	K091613	000
10841396118231	K091613	000
10841396118224	K091613	000
10841396118217	K091613	000
10841396118200	K091613	000
10841396118194	K091613	000
10841396118187	K091613	000
10841396118170	K091613	000
10841396118163	K091613	000
10841396118156	K091613	000
10841396118149	K091613	000
10841396118132	K091613	000
10841396118125	K091613	000
10841396118118	K091613	000
10841396118101	K091613	000
10841396118095	K091613	000
10841396118255	K091613	000
10841396118262	K091613	000
10841396118279	K091613	000
10841396118521	K091613	000
10841396118514	K091613	000
10841396118507	K091613	000
10841396118491	K091613	000
10841396118484	K091613	000
10841396118392	K091613	000
10841396118385	K091613	000
10841396118378	K091613	000
10841396118361	K091613	000
10841396118354	K091613	000
10841396118347	K091613	000
10841396118323	K091613	000
10841396118316	K091613	000
10841396118309	K091613	000
10841396118293	K091613	000
10841396118286	K091613	000
00841396118401	K091613	000