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FDA 510(k)

ALATUS VAGINAL BALLOON PACKING SYSTEM

K-Number: K092534 · 2009-12-07

ApplicantRadiadyne
Decision Date2009-12-07
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALATUS VAGINAL BALLOON PACKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiadyne. It received FDA 510(k) clearance on 2009-12-07 under 510(k) number K092534. 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 ALATUS VAGINAL BALLOON PACKING SYSTEM?

ALATUS VAGINAL BALLOON PACKING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-07. The listed applicant is Radiadyne. The 510(k) number is K092534.

When did ALATUS VAGINAL BALLOON PACKING SYSTEM receive FDA 510(k) clearance?

ALATUS VAGINAL BALLOON PACKING SYSTEM received FDA 510(k) clearance on 2009-12-07, under 510(k) number K092534.

Who is the listed applicant for ALATUS VAGINAL BALLOON PACKING SYSTEM?

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

What is the FDA product code for ALATUS VAGINAL BALLOON PACKING SYSTEM?

The FDA product code for ALATUS VAGINAL BALLOON PACKING SYSTEM is JAQ.

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Official Source

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

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