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