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FDA 510(k)

KPE PLUS-PAK SURGICAL SYSTEM

K-Number: K833962 · 1984-03-12

ApplicantIpax, Inc.
Decision Date1984-03-12
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KPE PLUS-PAK SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K833962. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KPE PLUS-PAK SURGICAL SYSTEM?

KPE PLUS-PAK SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Ipax, Inc.. The 510(k) number is K833962.

When did KPE PLUS-PAK SURGICAL SYSTEM receive FDA 510(k) clearance?

KPE PLUS-PAK SURGICAL SYSTEM received FDA 510(k) clearance on 1984-03-12, under 510(k) number K833962.

Who is the listed applicant for KPE PLUS-PAK SURGICAL SYSTEM?

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

What is the FDA product code for KPE PLUS-PAK SURGICAL SYSTEM?

The FDA product code for KPE PLUS-PAK SURGICAL SYSTEM is HQC.

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Related Devices (Code: HQC)

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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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