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FDA 510(k)

BED SHEET, PILLOW CASE

K-Number: K884380 · 1988-11-08

ApplicantSaybrex Intl., Inc.
Decision Date1988-11-08
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BED SHEET, PILLOW CASE is the device name listed in this FDA 510(k) record. The listed applicant is Saybrex Intl., Inc.. It received FDA 510(k) clearance on 1988-11-08 under 510(k) number K884380. 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 BED SHEET, PILLOW CASE?

BED SHEET, PILLOW CASE is a medical device that received FDA 510(k) clearance on 1988-11-08. The listed applicant is Saybrex Intl., Inc.. The 510(k) number is K884380.

When did BED SHEET, PILLOW CASE receive FDA 510(k) clearance?

BED SHEET, PILLOW CASE received FDA 510(k) clearance on 1988-11-08, under 510(k) number K884380.

Who is the listed applicant for BED SHEET, PILLOW CASE?

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

What is the FDA product code for BED SHEET, PILLOW CASE?

The FDA product code for BED SHEET, PILLOW CASE is KME.

Related Clinical Trials

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Other records listing Saybrex 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.

K884295SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE

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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