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FDA 510(k)

SURGICAL SIMPLEX P WITH TOBRAMYCIN

K-Number: K014199 · 2003-05-06

ApplicantHowmedica Osteonics Corp.
Decision Date2003-05-06
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICAL SIMPLEX P WITH TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2003-05-06 under 510(k) number K014199. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL SIMPLEX P WITH TOBRAMYCIN?

SURGICAL SIMPLEX P WITH TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K014199.

When did SURGICAL SIMPLEX P WITH TOBRAMYCIN receive FDA 510(k) clearance?

SURGICAL SIMPLEX P WITH TOBRAMYCIN received FDA 510(k) clearance on 2003-05-06, under 510(k) number K014199.

Who is the listed applicant for SURGICAL SIMPLEX P WITH TOBRAMYCIN?

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

What is the FDA product code for SURGICAL SIMPLEX P WITH TOBRAMYCIN?

The FDA product code for SURGICAL SIMPLEX P WITH TOBRAMYCIN is LOD.

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Related Devices (Code: LOD)

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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.

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