FDA 510(k)

CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407

K-Number: K122840 · 2012-12-14

ApplicantMick Radio-Nuclear Instruments, Inc.

Decision Date2012-12-14

Product CodeJAQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 is the device name listed in this FDA 510(k) record. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K122840. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407?

CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K122840.

When did CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 receive FDA 510(k) clearance?

CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 received FDA 510(k) clearance on 2012-12-14, under 510(k) number K122840.

Who is the listed applicant for CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407?

The FDA 510(k) record lists Mick Radio-Nuclear Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407?

The FDA product code for CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 is JAQ.

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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.