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FDA 510(k)

MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE

K-Number: K891986 · 1989-12-29

ApplicantMark One Healthcare Products
Decision Date1989-12-29
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE is the device name listed in this FDA 510(k) record. The listed applicant is Mark One Healthcare Products. It received FDA 510(k) clearance on 1989-12-29 under 510(k) number K891986. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE?

MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE is a medical device that received FDA 510(k) clearance on 1989-12-29. The listed applicant is Mark One Healthcare Products. The 510(k) number is K891986.

When did MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE receive FDA 510(k) clearance?

MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE received FDA 510(k) clearance on 1989-12-29, under 510(k) number K891986.

Who is the listed applicant for MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE?

The FDA 510(k) record lists Mark One Healthcare Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE?

The FDA product code for MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE is KME.

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Other records listing Mark One Healthcare Products 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.

K833867PAREMA K BAND NON-STERILEK833084MASTERHINGEK770396DRAPES, MODESTYK761268SKIN PRESSURE PROTECTORS

Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K915303FOIL BABY BUNTINGGam Industries, 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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