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FDA 510(k)

MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL

K-Number: K895819 · 1989-11-02

ApplicantMedi-Tech, Inc.
Decision Date1989-11-02
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1989-11-02 under 510(k) number K895819. 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 MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL?

MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL is a medical device that received FDA 510(k) clearance on 1989-11-02. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K895819.

When did MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL receive FDA 510(k) clearance?

MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL received FDA 510(k) clearance on 1989-11-02, under 510(k) number K895819.

Who is the listed applicant for MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL?

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

What is the FDA product code for MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL?

The FDA product code for MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL is KMF.

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Other records listing Medi-Tech, Inc. as applicant

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Related Devices (Code: KMF)

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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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