SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE— 510(k) K884295

Name: FDA 510(k) clearance K884295
Creator: U.S. Food and Drug Administration
Published: 1988-11-08

Substantially Equivalent

Saybrex Intl., Inc.

FDA 510(k) clearance K884295 for SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE, Substantially Equivalent on 1988-11-08. Applicant: Saybrex Intl., Inc.. Device class: 2.

Clearance details

Applicant: Saybrex Intl., Inc.
Product code: Code LGM
Device class: Class 2
Regulation: 21 CFR 880.5450
Advisory panel: General Hospital
Date received: 1988-10-12
Decision date: 1988-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

Download summary PDF View on FDA.gov ↗

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