BED SHEET, PILLOW CASE— 510(k) K884380

Substantially Equivalent

Saybrex Intl., Inc.

FDA 510(k) clearance K884380 for BED SHEET, PILLOW CASE, Substantially Equivalent on 1988-11-08. Applicant: Saybrex Intl., Inc.. Device class: 1.

Clearance details

Applicant: Saybrex Intl., Inc.
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1988-10-18
Decision date: 1988-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KME

K042145 — READY-HEAT BLANKET2004-09-17
K944953 — OREX MEDICAL BEDDING1994-12-02
K933636 — DISPOSE-A-SHEET1994-01-26
K932539 — DOCTOR DOWN --RESCUE WRAP1993-11-02
K922143 — AMERICAN BURN SHEET1992-08-10

More clearances from Saybrex Intl., Inc.

K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE1988-11-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.