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FDA 510(k)

EX-111 WOUND DRESSING

K-Number: K952907 · 1995-08-07

ApplicantVariseal Manufacturing Corp.
Decision Date1995-08-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

EX-111 WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Variseal Manufacturing Corp.. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K952907. 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 EX-111 WOUND DRESSING?

EX-111 WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Variseal Manufacturing Corp.. The 510(k) number is K952907.

When did EX-111 WOUND DRESSING receive FDA 510(k) clearance?

EX-111 WOUND DRESSING received FDA 510(k) clearance on 1995-08-07, under 510(k) number K952907.

Who is the listed applicant for EX-111 WOUND DRESSING?

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

What is the FDA product code for EX-111 WOUND DRESSING?

The FDA product code for EX-111 WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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