Cleared Traditional

K960218 - CONNECTING TUBING
(FDA 510(k) Clearance)

K960218 · Custom Pack Reliability · General Hospital

Mar 1996

Decision

72d

Days

Class 2

Risk

K960218 is an FDA 510(k) clearance for the CONNECTING TUBING, a Tube, Aspirating, Flexible, Connecting (Class II — Special Controls, product code BYY), submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on March 28, 1996, 72 days after receiving the submission on January 16, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number	K960218 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1996
Decision Date	March 28, 1996
Days to Decision	72 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement