FDA 510(k)

RX IV PENTRON IV

K-Number: K833285 · 1983-12-22

Decision Date1983-12-22

Product CodeEIS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

RX IV PENTRON IV is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Industries, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833285. The device is classified under product code EIS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX IV PENTRON IV?

RX IV PENTRON IV is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Genesis Industries, Inc.. The 510(k) number is K833285.

When did RX IV PENTRON IV receive FDA 510(k) clearance?

RX IV PENTRON IV received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833285.

Who is the listed applicant for RX IV PENTRON IV?

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

What is the FDA product code for RX IV PENTRON IV?

The FDA product code for RX IV PENTRON IV is EIS.

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Other records listing Genesis Industries, Inc. as applicant

K994361ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL K962828EVERT-IT K880377NOVO VIVO MODEL #17140 AND #17135 K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP K833287SATIN CAST ECONOCAST K833290C & B 40 PENTRO C & B40

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Related Devices (Code: EIS)

K992649ATD AUTOMATIC BRIDGE REMOVERJ. Morita USA, Inc.K951299EASY PNEUMATIC CROWN AND BRIDGE REMOVERDentco, Inc.K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARPacific Union Dental, Inc.K854795HAZELTON TEMPORARY CROWN AND BRIDGE REMOVERFran Hazelton Co.K842026H-TYPE BRIDGE REMOVERHiga Manufacturing , Ltd.K833290C & B 40 PENTRO C & B40Genesis Industries, Inc.

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.