FDA 510(k)

MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104

K-Number: K050319 · 2005-03-31

Decision Date2005-03-31

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2005-03-31 under 510(k) number K050319. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104?

MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 is a medical device that received FDA 510(k) clearance on 2005-03-31. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K050319.

When did MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 receive FDA 510(k) clearance?

MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 received FDA 510(k) clearance on 2005-03-31, under 510(k) number K050319.

Who is the listed applicant for MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104?

The FDA product code for MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 is HBL.

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Official Source

View on FDA Database →

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