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FDA 510(k)

FLEXIBLE ILLUMINATOR 5

K-Number: K840371 · 1984-04-24

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-04-24
Product CodeFTF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE ILLUMINATOR 5 is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K840371. The device is classified under product code FTF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE ILLUMINATOR 5?

FLEXIBLE ILLUMINATOR 5 is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840371.

When did FLEXIBLE ILLUMINATOR 5 receive FDA 510(k) clearance?

FLEXIBLE ILLUMINATOR 5 received FDA 510(k) clearance on 1984-04-24, under 510(k) number K840371.

Who is the listed applicant for FLEXIBLE ILLUMINATOR 5?

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

What is the FDA product code for FLEXIBLE ILLUMINATOR 5?

The FDA product code for FLEXIBLE ILLUMINATOR 5 is FTF.

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Other records listing Suncoast Medical Manufacturers, 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.

K841604ADJUST-A-TEMP HIGH TEMPERATUREK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

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Related Devices (Code: FTF)

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.

K041621LITEPORT LP100 SURGICAL ILLUMINATORMedical Vision Industries, Inc.K840372FLEXIBLE ILLUMINATOR 15Suncoast Medical Manufacturers, Inc.K840373FLEXIBLE ILLUMINATOR 10Suncoast Medical Manufacturers, 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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