CODMAN HAKIM MICRO II VALVE

Shunt, Central Nervous System And Components

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Hakim Micro Ii Valve.

Pre-market Notification Details

• Device ID: K091346
• 510k Number: K091346
• Device Name: CODMAN HAKIM MICRO II VALVE
• Classification: Shunt, Central Nervous System And Components
• Applicant: Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Contact: Sharon Mcdermott
• Correspondent: Sharon Mcdermott; Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-07
• Decision Date: 2009-06-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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