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FDA 510(k)

PILLOW COVER, ANTI-MICROBIAL

K-Number: K832486 · 1984-02-13

ApplicantAmerican Threshold Industries, Inc.
Decision Date1984-02-13
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PILLOW COVER, ANTI-MICROBIAL is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1984-02-13 under 510(k) number K832486. 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 PILLOW COVER, ANTI-MICROBIAL?

PILLOW COVER, ANTI-MICROBIAL is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K832486.

When did PILLOW COVER, ANTI-MICROBIAL receive FDA 510(k) clearance?

PILLOW COVER, ANTI-MICROBIAL received FDA 510(k) clearance on 1984-02-13, under 510(k) number K832486.

Who is the listed applicant for PILLOW COVER, ANTI-MICROBIAL?

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

What is the FDA product code for PILLOW COVER, ANTI-MICROBIAL?

The FDA product code for PILLOW COVER, ANTI-MICROBIAL is KME.

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Other records listing American Threshold 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.

K971483SECURE-WRAP (TM) STERILIZATION WRAPK953879SURGEON'S CAPK953878BOUFFANT CAPK952115BARRIER GOWN, KOOL-GARD BACKLESS GOWNK952114KOOL GARD SINGLES GOWNK952116COVER GOWN

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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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