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FDA 510(k)

SPAND-GEL GRANULATED GEL

K-Number: K864124 · 1986-11-26

ApplicantMedi-Tech Intl. Corp.
Decision Date1986-11-26
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPAND-GEL GRANULATED GEL is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech Intl. Corp.. It received FDA 510(k) clearance on 1986-11-26 under 510(k) number K864124. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SPAND-GEL GRANULATED GEL?

SPAND-GEL GRANULATED GEL is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Medi-Tech Intl. Corp.. The 510(k) number is K864124.

When did SPAND-GEL GRANULATED GEL receive FDA 510(k) clearance?

SPAND-GEL GRANULATED GEL received FDA 510(k) clearance on 1986-11-26, under 510(k) number K864124.

Who is the listed applicant for SPAND-GEL GRANULATED GEL?

The FDA 510(k) record lists Medi-Tech Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPAND-GEL GRANULATED GEL?

The FDA product code for SPAND-GEL GRANULATED GEL is KMF.

Related Clinical Trials

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Other records listing Medi-Tech Intl. 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.

K110377PROTECTIVE RESTRAINTK002666DIAMOND ALOE VERA, STERILE

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

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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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