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FDA 510(k)

SPENCIO SKIN GUARD KIT

K-Number: K910927 · 1991-06-03

ApplicantSpenco Medical Corp.
Decision Date1991-06-03
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPENCIO SKIN GUARD KIT 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 1991-06-03 under 510(k) number K910927. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPENCIO SKIN GUARD KIT?

SPENCIO SKIN GUARD KIT is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Spenco Medical Corp.. The 510(k) number is K910927.

When did SPENCIO SKIN GUARD KIT receive FDA 510(k) clearance?

SPENCIO SKIN GUARD KIT received FDA 510(k) clearance on 1991-06-03, under 510(k) number K910927.

Who is the listed applicant for SPENCIO SKIN GUARD KIT?

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 SPENCIO SKIN GUARD KIT?

The FDA product code for SPENCIO SKIN GUARD KIT is KMF.

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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 ALOEK896533SPENCO BREAST FORMSK8948982ND SKIN NON-STICK MOIST BURN PADSK820906SPENCO CRYOPRESS

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Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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