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FDA 510(k)

FLORET FOAM PREP SPONGE

K-Number: K833626 · 1984-02-17

ApplicantRitmed, Inc.
Decision Date1984-02-17
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLORET FOAM PREP SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Ritmed, Inc.. It received FDA 510(k) clearance on 1984-02-17 under 510(k) number K833626. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLORET FOAM PREP SPONGE?

FLORET FOAM PREP SPONGE is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Ritmed, Inc.. The 510(k) number is K833626.

When did FLORET FOAM PREP SPONGE receive FDA 510(k) clearance?

FLORET FOAM PREP SPONGE received FDA 510(k) clearance on 1984-02-17, under 510(k) number K833626.

Who is the listed applicant for FLORET FOAM PREP SPONGE?

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

What is the FDA product code for FLORET FOAM PREP SPONGE?

The FDA product code for FLORET FOAM PREP SPONGE is GDY.

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Other records listing Ritmed, 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.

K832874ISOVIS WOUND PROTECTORK830270ISOVIS WOUND PROTECTORK830261FLORET STRUNG GAUZE SPONGESK830268FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMINK830266FLORET KITTNER OR K DISSECTORK830267FLORET SPECIAL GAUZE SPONGES

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Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives 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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