NIOMED BOUFFANT CAPS— 510(k) K954455

Substantially Equivalent

Amerasia Corp.

FDA 510(k) clearance K954455 for NIOMED BOUFFANT CAPS, Substantially Equivalent on 1996-01-23. Applicant: Amerasia Corp.. Device class: 1.

Clearance details

Applicant: Amerasia Corp.
Product code: Code FYF
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1995-09-25
Decision date: 1996-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYF

K972227 — SHOE COVER1997-09-09
K955833 — NIOMED SURGICAL CAPS1996-03-15
K954556 — SURGICAL CAP1996-03-12
K954454 — NIOMED SURGICAL HOOD1996-01-23
K953878 — BOUFFANT CAP1996-01-05

More clearances from Amerasia Corp.

K954747 — NIOMED BARRIER GOWNS1996-03-06
K952897 — NIOMED SHOE COVERS1995-10-23
K952937 — NIOMED NON-SKID SHOE COVERS1995-10-23

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