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FDA 510(k)

WOODLYN CLASSIC REFRACTOR, PHOROPTOR

K-Number: K874900 · 1987-12-23

ApplicantWoodlyn, Inc.
Decision Date1987-12-23
Product CodeHKN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WOODLYN CLASSIC REFRACTOR, PHOROPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Woodlyn, Inc.. It received FDA 510(k) clearance on 1987-12-23 under 510(k) number K874900. The device is classified under product code HKN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOODLYN CLASSIC REFRACTOR, PHOROPTOR?

WOODLYN CLASSIC REFRACTOR, PHOROPTOR is a medical device that received FDA 510(k) clearance on 1987-12-23. The listed applicant is Woodlyn, Inc.. The 510(k) number is K874900.

When did WOODLYN CLASSIC REFRACTOR, PHOROPTOR receive FDA 510(k) clearance?

WOODLYN CLASSIC REFRACTOR, PHOROPTOR received FDA 510(k) clearance on 1987-12-23, under 510(k) number K874900.

Who is the listed applicant for WOODLYN CLASSIC REFRACTOR, PHOROPTOR?

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 REFRACTOR, PHOROPTOR?

The FDA product code for WOODLYN CLASSIC REFRACTOR, PHOROPTOR is HKN.

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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 LENSMETERK900476WOODLYN SLIT LAMP MODEL HR-1K900477WOODLYN CLASSIC SLIT LAMP MODEL SMMK900478WOODLYN FULL APERTURE TRIAL LENS SETK890992WOODLYN OPHTHALMIC PROJECTOR

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Related Devices (Code: HKN)

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.

K936205COMPREHENSIVE PHOROPTER, MDR-680Canon USA, Inc.K782118FUL-VUEAmerican Optical Corp.

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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