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FDA 510(k)

STERILE HAND COVER

K-Number: K894064 · 1989-08-11

ApplicantSage Products, Inc.
Decision Date1989-08-11
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE HAND COVER is the device name listed in this FDA 510(k) record. The listed applicant is Sage Products, Inc.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K894064. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE HAND COVER?

STERILE HAND COVER is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Sage Products, Inc.. The 510(k) number is K894064.

When did STERILE HAND COVER receive FDA 510(k) clearance?

STERILE HAND COVER received FDA 510(k) clearance on 1989-08-11, under 510(k) number K894064.

Who is the listed applicant for STERILE HAND COVER?

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

What is the FDA product code for STERILE HAND COVER?

The FDA product code for STERILE HAND COVER is LYU.

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Other records listing Sage Products, 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.

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK9739112 GALLON ALTERNATE CARE SHARPS CONTAINERK972279SHARPS SHUTTLEK970135NITRILE GLOVESK972302POCKET COUNT OR SAFETCOUNT

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Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., 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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