CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231

Drills, Burrs, Trephines & Accessories (compound, Powered)

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231.

Pre-market Notification Details

• Device ID: K073336
• 510k Number: K073336
• Device Name: CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
• Classification: Drills, Burrs, Trephines & Accessories (compound, Powered)
• Applicant: Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Contact: Emily E Valerio
• Correspondent: Emily E Valerio; Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350
• Product Code: HBF
• CFR Regulation Number: 882.4305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-28
• Decision Date: 2008-01-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780513629	K073336	000
10886704005131	K073336	000