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FDA 510(k)

RX 96E

K-Number: K963891 · 1996-11-19

ApplicantJeneric/Pentron, Inc.
Decision Date1996-11-19
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX 96E is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K963891. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX 96E?

RX 96E is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K963891.

When did RX 96E receive FDA 510(k) clearance?

RX 96E received FDA 510(k) clearance on 1996-11-19, under 510(k) number K963891.

Who is the listed applicant for RX 96E?

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

What is the FDA product code for RX 96E?

The FDA product code for RX 96E is EJH.

Other records listing Jeneric/Pentron, 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.

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Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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