Cleared Traditional

K883220 - EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS
(FDA 510(k) Clearance)

K883220 · Cancer Technologies, Inc. · General Hospital

Oct 1988

Decision

83d

Days

Class 2

Risk

K883220 is an FDA 510(k) clearance for the EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS. This device is classified as a Syringe, Piston (Class II — Special Controls, product code FMF).

Submitted by Cancer Technologies, Inc. (Tucson, US). The FDA issued a Cleared decision on October 20, 1988, 83 days after receiving the submission on July 29, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K883220 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 1988
Decision Date	October 20, 1988
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—