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FDA 510(k)

PROACT WITH GEL OR PROACT 1

K-Number: K052243 · 2006-04-12

ApplicantProact, Inc.
Decision Date2006-04-12
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROACT WITH GEL OR PROACT 1 is the device name listed in this FDA 510(k) record. The listed applicant is Proact, Inc.. It received FDA 510(k) clearance on 2006-04-12 under 510(k) number K052243. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROACT WITH GEL OR PROACT 1?

PROACT WITH GEL OR PROACT 1 is a medical device that received FDA 510(k) clearance on 2006-04-12. The listed applicant is Proact, Inc.. The 510(k) number is K052243.

When did PROACT WITH GEL OR PROACT 1 receive FDA 510(k) clearance?

PROACT WITH GEL OR PROACT 1 received FDA 510(k) clearance on 2006-04-12, under 510(k) number K052243.

Who is the listed applicant for PROACT WITH GEL OR PROACT 1?

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

What is the FDA product code for PROACT WITH GEL OR PROACT 1?

The FDA product code for PROACT WITH GEL OR PROACT 1 is JOW.

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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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