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FDA 510(k)

PISTORMATIC

K-Number: K790104 · 1979-05-14

ApplicantZelby, Burstein, Hartman & Burstein
Decision Date1979-05-14
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PISTORMATIC is the device name listed in this FDA 510(k) record. The listed applicant is Zelby, Burstein, Hartman & Burstein. It received FDA 510(k) clearance on 1979-05-14 under 510(k) number K790104. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PISTORMATIC?

PISTORMATIC is a medical device that received FDA 510(k) clearance on 1979-05-14. The listed applicant is Zelby, Burstein, Hartman & Burstein. The 510(k) number is K790104.

When did PISTORMATIC receive FDA 510(k) clearance?

PISTORMATIC received FDA 510(k) clearance on 1979-05-14, under 510(k) number K790104.

Who is the listed applicant for PISTORMATIC?

The FDA 510(k) record lists Zelby, Burstein, Hartman & Burstein as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PISTORMATIC?

The FDA product code for PISTORMATIC is KZH.

Related Clinical Trials

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Related Devices (Code: KZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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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