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FDA 510(k)

VACUGUARD(TM)

K-Number: K880594 · 1988-04-28

ApplicantHabley Medical Technology Corp.
Decision Date1988-04-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUGUARD(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Habley Medical Technology Corp.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K880594. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUGUARD(TM)?

VACUGUARD(TM) is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Habley Medical Technology Corp.. The 510(k) number is K880594.

When did VACUGUARD(TM) receive FDA 510(k) clearance?

VACUGUARD(TM) received FDA 510(k) clearance on 1988-04-28, under 510(k) number K880594.

Who is the listed applicant for VACUGUARD(TM)?

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

What is the FDA product code for VACUGUARD(TM)?

The FDA product code for VACUGUARD(TM) is JKA.

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Other records listing Habley Medical Technology Corp. as applicant

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Related Devices (Code: JKA)

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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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