HEMO-BARRIER— 510(k) K953500

Substantially Equivalent

Asia Dynamics, Inc.

FDA 510(k) clearance K953500 for HEMO-BARRIER, Substantially Equivalent on 1996-01-24. Applicant: Asia Dynamics, Inc.. Device class: 1.

Clearance details

Applicant: Asia Dynamics, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1995-07-26
Decision date: 1996-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Asia Dynamics, Inc.

K953501 — ADI STERILE GAUZE SPONGES1995-08-28
K952924 — ADI CATHETER WITH VALVE1995-08-18
K891160 — MIC NON-STERILE LATEX GLOVES1989-10-13

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