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FDA 510(k)

WOODLYN CLASSIC EXAM. CHAIR

K-Number: K842045 · 1984-06-19

ApplicantWoodlyn, Inc.
Decision Date1984-06-19
Product CodeHME
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WOODLYN CLASSIC EXAM. CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Woodlyn, Inc.. It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K842045. 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 WOODLYN CLASSIC EXAM. CHAIR?

WOODLYN CLASSIC EXAM. CHAIR is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Woodlyn, Inc.. The 510(k) number is K842045.

When did WOODLYN CLASSIC EXAM. CHAIR receive FDA 510(k) clearance?

WOODLYN CLASSIC EXAM. CHAIR received FDA 510(k) clearance on 1984-06-19, under 510(k) number K842045.

Who is the listed applicant for WOODLYN CLASSIC EXAM. CHAIR?

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

What is the FDA product code for WOODLYN CLASSIC EXAM. CHAIR?

The FDA product code for WOODLYN CLASSIC EXAM. CHAIR is HME.

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Other records listing Woodlyn, 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.

K931303WOODLYN OPERATION MICROSCOPEK920861WOODLYN CLASSIC LENSMETERK900478WOODLYN FULL APERTURE TRIAL LENS SETK900476WOODLYN SLIT LAMP MODEL HR-1K900477WOODLYN CLASSIC SLIT LAMP MODEL SMMK890992WOODLYN OPHTHALMIC PROJECTOR

View all 19 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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