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FDA 510(k)

RX NYSP PENTRON 60

K-Number: K833282 · 1983-11-28

ApplicantGenesis Industries, Inc.
Decision Date1983-11-28
Product CodeEIS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX NYSP PENTRON 60 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 1983-11-28 under 510(k) number K833282. 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 NYSP PENTRON 60?

RX NYSP PENTRON 60 is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Genesis Industries, Inc.. The 510(k) number is K833282.

When did RX NYSP PENTRON 60 receive FDA 510(k) clearance?

RX NYSP PENTRON 60 received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833282.

Who is the listed applicant for RX NYSP PENTRON 60?

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 NYSP PENTRON 60?

The FDA product code for RX NYSP PENTRON 60 is EIS.

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Other records listing Genesis Industries, 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.

K994361ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELLK962828EVERT-ITK880377NOVO VIVO MODEL #17140 AND #17135K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPK833287SATIN CAST ECONOCASTK833290C & B 40 PENTRO C & B40

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Related Devices (Code: EIS)

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.

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.

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