Cleared Traditional

K883242 - EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO)
(FDA 510(k) Clearance)

K883242 · Cancer Technologies, Inc. · General Hospital

Oct 1988

Decision

71d

Days

Class 2

Risk

K883242 is an FDA 510(k) clearance for the EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO). 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 12, 1988, 71 days after receiving the submission on August 2, 1988.

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

Submission Details

510(k) Number	K883242 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1988
Decision Date	October 12, 1988
Days to Decision	71 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—