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FDA 510(k)

DEVON DISPOSABLE HEAD POSITIONER COVER

K-Number: K894170 · 1989-09-07

ApplicantDevon Industries, Inc.
Decision Date1989-09-07
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEVON DISPOSABLE HEAD POSITIONER COVER is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1989-09-07 under 510(k) number K894170. 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 DEVON DISPOSABLE HEAD POSITIONER COVER?

DEVON DISPOSABLE HEAD POSITIONER COVER is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Devon Industries, Inc.. The 510(k) number is K894170.

When did DEVON DISPOSABLE HEAD POSITIONER COVER receive FDA 510(k) clearance?

DEVON DISPOSABLE HEAD POSITIONER COVER received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894170.

Who is the listed applicant for DEVON DISPOSABLE HEAD POSITIONER COVER?

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

What is the FDA product code for DEVON DISPOSABLE HEAD POSITIONER COVER?

The FDA product code for DEVON DISPOSABLE HEAD POSITIONER COVER is KME.

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Other records listing Devon Industries, 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.

K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)K954015ABG POINT LOK NEEDLE PROTECTION DEVICEK946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEK943892POINT OF USE SHARPS A GATORK945197THE SHARPS COLLECTION AND DISPOSAL SYSTEMK944114PHLEBOTOMY UNIT SHARPS A GATOR

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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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