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FDA 510(k)

NATURELLE-LITE

K-Number: K833279 · 1983-11-28

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

Device Summary

NATURELLE-LITE 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 K833279. 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 NATURELLE-LITE?

NATURELLE-LITE 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 K833279.

When did NATURELLE-LITE receive FDA 510(k) clearance?

NATURELLE-LITE received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833279.

Who is the listed applicant for NATURELLE-LITE?

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 NATURELLE-LITE?

The FDA product code for NATURELLE-LITE 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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