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FDA 510(k)

RECLOSABLE WOUND COVER

K-Number: K954621 · 1995-10-23

ApplicantHollister, Inc.
Decision Date1995-10-23
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

RECLOSABLE WOUND COVER is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K954621. 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 for Some Indications.

Frequently Asked Questions

What is the RECLOSABLE WOUND COVER?

RECLOSABLE WOUND COVER is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Hollister, Inc.. The 510(k) number is K954621.

When did RECLOSABLE WOUND COVER receive FDA 510(k) clearance?

RECLOSABLE WOUND COVER received FDA 510(k) clearance on 1995-10-23, under 510(k) number K954621.

Who is the listed applicant for RECLOSABLE WOUND COVER?

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

What is the FDA product code for RECLOSABLE WOUND COVER?

The FDA product code for RECLOSABLE WOUND COVER is FRO. This falls under the Anesthesiology category.

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Other records listing Hollister, 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.

K123804INSTAFLO BOWEL CATHETER SYSTEM KITK100273INSTAFLO BOWEL CATHETER SYSTEM KITK090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007K050483EVADRI BLADDER CONTROL SYSTEMSK040779RESTORE WOUND CLEANSER

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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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