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FDA 510(k)

DISPOSA-SPEC

K-Number: K840593 · 1984-07-13

ApplicantPlasti-Products, Inc.
Decision Date1984-07-13
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DISPOSA-SPEC is the device name listed in this FDA 510(k) record. The listed applicant is Plasti-Products, Inc.. It received FDA 510(k) clearance on 1984-07-13 under 510(k) number K840593. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSA-SPEC?

DISPOSA-SPEC is a medical device that received FDA 510(k) clearance on 1984-07-13. The listed applicant is Plasti-Products, Inc.. The 510(k) number is K840593.

When did DISPOSA-SPEC receive FDA 510(k) clearance?

DISPOSA-SPEC received FDA 510(k) clearance on 1984-07-13, under 510(k) number K840593.

Who is the listed applicant for DISPOSA-SPEC?

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

What is the FDA product code for DISPOSA-SPEC?

The FDA product code for DISPOSA-SPEC is ERA.

Related Clinical Trials

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.

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Other records listing Plasti-Products, Inc. as applicant

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.

K840595E-Z OPEN DUST COVERS

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.

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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