BLUE SHARK

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

MERIDAN MEDICAL

The following data is part of a premarket notification filed by Meridan Medical with the FDA for Blue Shark.

Pre-market Notification Details

• Device ID: K070016
• 510k Number: K070016
• Device Name: BLUE SHARK
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: MERIDAN MEDICAL 3722 AVE. SAUSALITO Irvine, CA 92606
• Contact: Grace Holland
• Correspondent: Grace Holland; MERIDAN MEDICAL 3722 AVE. SAUSALITO Irvine, CA 92606
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-03
• Decision Date: 2007-04-02
• Summary: summary