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FDA 510(k)

SIS FACIAL CYLINDER, SIS FACIAL IMPLANT

K-Number: K070738 · 2007-04-05

ApplicantCook Biotech, Inc.
Decision Date2007-04-05
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIS FACIAL CYLINDER, SIS FACIAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2007-04-05 under 510(k) number K070738. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIS FACIAL CYLINDER, SIS FACIAL IMPLANT?

SIS FACIAL CYLINDER, SIS FACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 2007-04-05. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K070738.

When did SIS FACIAL CYLINDER, SIS FACIAL IMPLANT receive FDA 510(k) clearance?

SIS FACIAL CYLINDER, SIS FACIAL IMPLANT received FDA 510(k) clearance on 2007-04-05, under 510(k) number K070738.

Who is the listed applicant for SIS FACIAL CYLINDER, SIS FACIAL IMPLANT?

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

What is the FDA product code for SIS FACIAL CYLINDER, SIS FACIAL IMPLANT?

The FDA product code for SIS FACIAL CYLINDER, SIS FACIAL IMPLANT is FTM.

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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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