ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR— 510(k) K980917

Clearance details

Applicant

Fortune Medical Instrument Corp.

Product code

Code GCA

Device class

Class 2

Regulation

21 CFR 876.5010

Advisory panel

Gastroenterology, Urology

Date received

1998-03-11

Decision date

1998-05-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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