Cleared Traditional

VIVASPIN 4 10,000 MW

K960298 · Vivascience, Inc. · Chemistry

Mar 1996

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K960298 is an FDA 510(k) clearance for the VIVASPIN 4 10,000 MW, a Clinical Sample Concentrator (Class I — General Controls, product code JJH), submitted by Vivascience, Inc. (Acton, US). The FDA issued a Cleared decision on March 19, 1996, 57 days after receiving the submission on January 22, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number	K960298 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 1996
Decision Date	March 19, 1996
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement