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FDA 510(k)

PRONTOSAN ANTIMICROBIAL WOUND GEL

K-Number: K101882 · 2010-11-03

ApplicantB.Braun Medical, Inc.
Decision Date2010-11-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PRONTOSAN ANTIMICROBIAL WOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2010-11-03 under 510(k) number K101882. 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 PRONTOSAN ANTIMICROBIAL WOUND GEL?

PRONTOSAN ANTIMICROBIAL WOUND GEL is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K101882.

When did PRONTOSAN ANTIMICROBIAL WOUND GEL receive FDA 510(k) clearance?

PRONTOSAN ANTIMICROBIAL WOUND GEL received FDA 510(k) clearance on 2010-11-03, under 510(k) number K101882.

Who is the listed applicant for PRONTOSAN ANTIMICROBIAL WOUND GEL?

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

What is the FDA product code for PRONTOSAN ANTIMICROBIAL WOUND GEL?

The FDA product code for PRONTOSAN ANTIMICROBIAL WOUND GEL is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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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