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FDA 510(k)

-OM WEST 2000 GNATUS CHAIR

K-Number: K863008 · 1986-09-24

ApplicantSds Dental, Inc.
Decision Date1986-09-24
Product CodeHME
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

-OM WEST 2000 GNATUS CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Sds Dental, Inc.. It received FDA 510(k) clearance on 1986-09-24 under 510(k) number K863008. The device is classified under product code HME. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the -OM WEST 2000 GNATUS CHAIR?

-OM WEST 2000 GNATUS CHAIR is a medical device that received FDA 510(k) clearance on 1986-09-24. The listed applicant is Sds Dental, Inc.. The 510(k) number is K863008.

When did -OM WEST 2000 GNATUS CHAIR receive FDA 510(k) clearance?

-OM WEST 2000 GNATUS CHAIR received FDA 510(k) clearance on 1986-09-24, under 510(k) number K863008.

Who is the listed applicant for -OM WEST 2000 GNATUS CHAIR?

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

What is the FDA product code for -OM WEST 2000 GNATUS CHAIR?

The FDA product code for -OM WEST 2000 GNATUS CHAIR is HME.

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Other records listing Sds Dental, 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.

K990546DELSONIC 2000K990545JETSONIC 2000K964619DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)K902865BAUMER SURGICAL TABLEK902864SURGICAL LIGHTING-CENTRA 450K863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II

View all 21 devices →

Related Devices (Code: HME)

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.

K930449MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIRMarco Ophthalmic, Inc.K914416BREATH-EASY, MODIFICATIONIcor ABK894018RELIANCE(R) 6200 EXAMINATION CHAIRReliance Medical Products, Inc.K870112STORZ ENT/OPHTHALMIC MAXI CHAIRStorz Instrument Co.K864494MODEL 6500 OPTHALMIC CHAIRKoken Mfg Company, Inc.K864574MAC 150E OPTHALMIC CHAIRKoken Mfg Company, 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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