ISOLAIR 2 FULL FACE SPLASH GUARD— 510(k) K931288

Name: FDA 510(k) clearance K931288
Creator: U.S. Food and Drug Administration
Published: 1994-01-21

Substantially Equivalent

Louis M. Gerson Co., Inc.

FDA 510(k) clearance K931288 for ISOLAIR 2 FULL FACE SPLASH GUARD, Substantially Equivalent on 1994-01-21. Applicant: Louis M. Gerson Co., Inc.. Device class: 1.

Clearance details

Applicant: Louis M. Gerson Co., Inc.
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1993-03-12
Decision date: 1994-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYU

view all

K011755 — STRYKER T4 HYTREL (R) TOGAS2001-06-22
K965237 — NURSES BOUFFANT CAP1997-08-27
K970988 — FAR-EAST BOUFFANT CAPS1997-07-10
K964364 — DISPOSABLE APRON1997-02-25
K961791 — DEPUY DISPOSABLE FILTER/HOOD1996-08-09

More clearances from Louis M. Gerson Co., Inc.

view all

K061375 — RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 17302006-11-17
K050193 — GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR2005-04-11
K960778 — ISOLAIR APR TYPE N951996-05-09
K925185 — ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS1994-02-03
K922507 — GERSON ISOLAIR APR PARTICULATE SURGICAL MASK1992-11-16

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