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FDA 510(k)

WOODLYN LIGHTWEIGHT TRIAL FRAME

K-Number: K841768 · 1984-06-01

ApplicantWoodlyn, Inc.
Decision Date1984-06-01
Product CodeHPA
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WOODLYN LIGHTWEIGHT TRIAL FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Woodlyn, Inc.. It received FDA 510(k) clearance on 1984-06-01 under 510(k) number K841768. The device is classified under product code HPA. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOODLYN LIGHTWEIGHT TRIAL FRAME?

WOODLYN LIGHTWEIGHT TRIAL FRAME is a medical device that received FDA 510(k) clearance on 1984-06-01. The listed applicant is Woodlyn, Inc.. The 510(k) number is K841768.

When did WOODLYN LIGHTWEIGHT TRIAL FRAME receive FDA 510(k) clearance?

WOODLYN LIGHTWEIGHT TRIAL FRAME received FDA 510(k) clearance on 1984-06-01, under 510(k) number K841768.

Who is the listed applicant for WOODLYN LIGHTWEIGHT TRIAL FRAME?

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 LIGHTWEIGHT TRIAL FRAME?

The FDA product code for WOODLYN LIGHTWEIGHT TRIAL FRAME is HPA.

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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

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Related Devices (Code: HPA)

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.

K852548ATL 225 MW TRAIL LENS SETAscon Medical Instruments, Ltd.K852126ATF 101 TRAIL FRAMEAscon Medical Instruments, Ltd.K833669IMAGE DEFLECTORMichael OnufrykK821084UNIVERSAL TRIAL FRAMEEMedical Equipment Designs, 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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