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FDA 510(k)

S12X WITH ESAX OPTION

K-Number: K082629 · 2009-07-01

ApplicantChatten Associates, Inc.
Decision Date2009-07-01
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

S12X WITH ESAX OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Chatten Associates, Inc.. It received FDA 510(k) clearance on 2009-07-01 under 510(k) number K082629. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S12X WITH ESAX OPTION?

S12X WITH ESAX OPTION is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is Chatten Associates, Inc.. The 510(k) number is K082629.

When did S12X WITH ESAX OPTION receive FDA 510(k) clearance?

S12X WITH ESAX OPTION received FDA 510(k) clearance on 2009-07-01, under 510(k) number K082629.

Who is the listed applicant for S12X WITH ESAX OPTION?

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

What is the FDA product code for S12X WITH ESAX OPTION?

The FDA product code for S12X WITH ESAX OPTION is GYC.

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Official Source

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