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FDA 510(k)

CUSTOM DRESSING CHANGE TRAYS

K-Number: K791738 · 1979-10-02

ApplicantSterile Design, Inc.
Decision Date1979-10-02
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUSTOM DRESSING CHANGE TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1979-10-02 under 510(k) number K791738. The device is classified under product code FMC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM DRESSING CHANGE TRAYS?

CUSTOM DRESSING CHANGE TRAYS is a medical device that received FDA 510(k) clearance on 1979-10-02. The listed applicant is Sterile Design, Inc.. The 510(k) number is K791738.

When did CUSTOM DRESSING CHANGE TRAYS receive FDA 510(k) clearance?

CUSTOM DRESSING CHANGE TRAYS received FDA 510(k) clearance on 1979-10-02, under 510(k) number K791738.

Who is the listed applicant for CUSTOM DRESSING CHANGE TRAYS?

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

What is the FDA product code for CUSTOM DRESSING CHANGE TRAYS?

The FDA product code for CUSTOM DRESSING CHANGE TRAYS is FMC.

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Other records listing Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK842356CUSTOM STERILE PROCEDURE KITSK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK841958CARDIO METRICS CARDIOTOMY RESERVOIRK842351STERILE DESIGN-CUSTOM STERILE IV KIT

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Related Devices (Code: FMC)

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.

K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., 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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