Cleared Traditional

K874807 - EXTRAVAKIT
(FDA 510(k) Clearance)

K874807 · Cancer Technologies, Inc. · General Hospital

Feb 1988

Decision

76d

Days

Class 2

Risk

K874807 is an FDA 510(k) clearance for the EXTRAVAKIT. 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 February 4, 1988, 76 days after receiving the submission on November 20, 1987.

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

Submission Details

510(k) Number	K874807 FDA.gov
FDA Decision	Cleared SESD
Date Received	November 20, 1987
Decision Date	February 04, 1988
Days to Decision	76 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—