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FDA 510(k)

MEDICAL, DISPOSABLE BEDDING

K-Number: K850067 · 1985-04-19

ApplicantEast Texas Lighthouse For the Blind
Decision Date1985-04-19
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICAL, DISPOSABLE BEDDING is the device name listed in this FDA 510(k) record. The listed applicant is East Texas Lighthouse For the Blind. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K850067. 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 MEDICAL, DISPOSABLE BEDDING?

MEDICAL, DISPOSABLE BEDDING is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is East Texas Lighthouse For the Blind. The 510(k) number is K850067.

When did MEDICAL, DISPOSABLE BEDDING receive FDA 510(k) clearance?

MEDICAL, DISPOSABLE BEDDING received FDA 510(k) clearance on 1985-04-19, under 510(k) number K850067.

Who is the listed applicant for MEDICAL, DISPOSABLE BEDDING?

The FDA 510(k) record lists East Texas Lighthouse For the Blind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICAL, DISPOSABLE BEDDING?

The FDA product code for MEDICAL, DISPOSABLE BEDDING is KME.

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Other records listing East Texas Lighthouse For the Blind 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.

K883376STERILIZATION WRAP TYPE 22,44,77K882275STERILE PACK (PROCEDURAL TRAY/KITS)K863733TOWEL PACK, SURGICALK862062NONWOVEN SURGICAL DRAPE PACKK850811PAD, PRE-OPERATIVE PREPARATIONK850016TOWEL PACK, SURGICAL

View all 7 devices →

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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