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FDA 510(k)

COVER, SHOE OPERATING ROOM

K-Number: K865023 · 1987-01-12

ApplicantUlti-Med Intl., Inc.
Decision Date1987-01-12
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COVER, SHOE OPERATING ROOM is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1987-01-12 under 510(k) number K865023. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVER, SHOE OPERATING ROOM?

COVER, SHOE OPERATING ROOM is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K865023.

When did COVER, SHOE OPERATING ROOM receive FDA 510(k) clearance?

COVER, SHOE OPERATING ROOM received FDA 510(k) clearance on 1987-01-12, under 510(k) number K865023.

Who is the listed applicant for COVER, SHOE OPERATING ROOM?

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

What is the FDA product code for COVER, SHOE OPERATING ROOM?

The FDA product code for COVER, SHOE OPERATING ROOM is FXP.

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Other records listing Ulti-Med Intl., Inc. 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.

K103011ULTICARE SAFETY INSULIN SYRINGEK923175SURGICAL INSTRUMENT KIT, DISPOSABLEK923176SURGICAL INSTRUMENT KIT, DISPOSABLEK920989SURGICAL INSTRUMENT KIT, DISPOSABLEK922828ULCER WOUND TRAYK914244STERILE CUSTOM SURGICAL KITS

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Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.

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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