FDA 510(k)

ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

K-Number: K071703 · 2007-08-22

Decision Date2007-08-22

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC is the device name listed in this FDA 510(k) record. The listed applicant is Swiss American Products, Inc.. It received FDA 510(k) clearance on 2007-08-22 under 510(k) number K071703. 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 ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC?

ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC is a medical device that received FDA 510(k) clearance on 2007-08-22. The listed applicant is Swiss American Products, Inc.. The 510(k) number is K071703.

When did ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC receive FDA 510(k) clearance?

ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC received FDA 510(k) clearance on 2007-08-22, under 510(k) number K071703.

Who is the listed applicant for ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC?

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

What is the FDA product code for ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC?

The FDA product code for ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC 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 Swiss American Products, Inc. as applicant

K103713ELTA WOUND CLEANSER K073610ELTA ADVANCED WOUND WASH K932291EUTRA GEL FOR WOUND DRESSING

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.