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FDA 510(k)

2ND SKIN NON-STICK MOIST BURN PADS

K-Number: K894898 · 1989-08-23

ApplicantSpenco Medical Corp.
Decision Date1989-08-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

2ND SKIN NON-STICK MOIST BURN PADS is the device name listed in this FDA 510(k) record. The listed applicant is Spenco Medical Corp.. It received FDA 510(k) clearance on 1989-08-23 under 510(k) number K894898. 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 2ND SKIN NON-STICK MOIST BURN PADS?

2ND SKIN NON-STICK MOIST BURN PADS is a medical device that received FDA 510(k) clearance on 1989-08-23. The listed applicant is Spenco Medical Corp.. The 510(k) number is K894898.

When did 2ND SKIN NON-STICK MOIST BURN PADS receive FDA 510(k) clearance?

2ND SKIN NON-STICK MOIST BURN PADS received FDA 510(k) clearance on 1989-08-23, under 510(k) number K894898.

Who is the listed applicant for 2ND SKIN NON-STICK MOIST BURN PADS?

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

What is the FDA product code for 2ND SKIN NON-STICK MOIST BURN PADS?

The FDA product code for 2ND SKIN NON-STICK MOIST BURN PADS is FRO. This falls under the Anesthesiology category.

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Other records listing Spenco Medical 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.

K981902SPENCO SILICONE GEL SHEETK9222282ND SKIN STERILE ADHESIVE STRIPK9115502ND SKIN MOIST BURN PADS WITH ALOEK910927SPENCIO SKIN GUARD KITK896533SPENCO BREAST FORMSK820906SPENCO CRYOPRESS

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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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