FDA 510(k)

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

K-Number: K073336 · 2008-01-04

Decision Date2008-01-04

Product CodeHBF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2008-01-04 under 510(k) number K073336. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231?

CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 is a medical device that received FDA 510(k) clearance on 2008-01-04. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K073336.

When did CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 receive FDA 510(k) clearance?

CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 received FDA 510(k) clearance on 2008-01-04, under 510(k) number K073336.

Who is the listed applicant for CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231?

The FDA product code for CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 is HBF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.