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FDA 510(k)

PARKE-DAVIS SURGICAL LIGHT

K-Number: K801353 · 1980-06-30

ApplicantWarner-Lambert Co.
Decision Date1980-06-30
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARKE-DAVIS SURGICAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801353. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARKE-DAVIS SURGICAL LIGHT?

PARKE-DAVIS SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Warner-Lambert Co.. The 510(k) number is K801353.

When did PARKE-DAVIS SURGICAL LIGHT receive FDA 510(k) clearance?

PARKE-DAVIS SURGICAL LIGHT received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801353.

Who is the listed applicant for PARKE-DAVIS SURGICAL LIGHT?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARKE-DAVIS SURGICAL LIGHT?

The FDA product code for PARKE-DAVIS SURGICAL LIGHT is FTD.

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Other records listing Warner-Lambert Co. as applicant

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Related Devices (Code: FTD)

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.

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLCK130513VOLISTA 400; VOLISTA 600Maquet S.A.S.K123776POLARIS 100/200Drager Medical GmbHK111020ATRICURE DISSECTORAtriCure, Inc.K100234HM-LAMP IIHillusa, Inc.K100884STRYKER KNIFELIGHTHowmedica Osteonics 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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