CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS

Device, Monitoring, Intracranial Pressure

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Single And Double Lumen Skull Bolt Kits.

Pre-market Notification Details

• Device ID: K992591
• 510k Number: K992591
• Device Name: CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
• Classification: Device, Monitoring, Intracranial Pressure
• Applicant: Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Contact: James M Flaherty
• Correspondent: James M Flaherty; Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: GWM
• CFR Regulation Number: 882.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-02
• Decision Date: 1999-10-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10886704042501	K992591	000