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FDA 510(k)

EXUSORB(TM) GRANULES

K-Number: K894996 · 1989-09-28

ApplicantControlled Therapeutics Corp.
Decision Date1989-09-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

EXUSORB(TM) GRANULES is the device name listed in this FDA 510(k) record. The listed applicant is Controlled Therapeutics Corp.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894996. 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 EXUSORB(TM) GRANULES?

EXUSORB(TM) GRANULES is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Controlled Therapeutics Corp.. The 510(k) number is K894996.

When did EXUSORB(TM) GRANULES receive FDA 510(k) clearance?

EXUSORB(TM) GRANULES received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894996.

Who is the listed applicant for EXUSORB(TM) GRANULES?

The FDA 510(k) record lists Controlled Therapeutics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXUSORB(TM) GRANULES?

The FDA product code for EXUSORB(TM) GRANULES is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Controlled Therapeutics Corp. 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.

K896176EXUSORB(TM) DRY/WET DRESSINGK895606EXUSORB(TM) GEL DRESSINGK894274EXUSORB TRANSPARENT DRESSING

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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