PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA— 510(k) K061991

Clearance details

Applicant

Helena Laboratories

Product code

Code GHR

Device class

Class 2

Regulation

21 CFR 864.5700

Advisory panel

Hematology

Date received

2006-07-13

Decision date

2007-02-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beaumont, TX, US

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