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FDA 510(k)

SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)

K-Number: K932676 · 1993-12-10

ApplicantPolymedica Industries, Inc.
Decision Date1993-12-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) is the device name listed in this FDA 510(k) record. The listed applicant is Polymedica Industries, Inc.. It received FDA 510(k) clearance on 1993-12-10 under 510(k) number K932676. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)?

SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K932676.

When did SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) receive FDA 510(k) clearance?

SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) received FDA 510(k) clearance on 1993-12-10, under 510(k) number K932676.

Who is the listed applicant for SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)?

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

What is the FDA product code for SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)?

The FDA product code for SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) is FRO. This falls under the Anesthesiology category.

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Other records listing Polymedica Industries, 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.

K964398SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDK971045BASIS FLEXIBLE TIP DIGITAL THERMOMETERK964701MITRAFLEX PIGMENTED WOUND DRESSINGK963623SPYROFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK955383SPYROCOLLOID WOUND DRESSING

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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