Cleared Traditional

BARI-KAD PACKING DEVICE

K050318 · Bioenvelop Agro, Inc. · Dental

Mar 2005

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K050318 is an FDA 510(k) clearance for the BARI-KAD PACKING DEVICE, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by Bioenvelop Agro, Inc. (West Cadwell, US). The FDA issued a Cleared decision on March 4, 2005, 23 days after receiving the submission on February 9, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number	K050318 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2005
Decision Date	March 04, 2005
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement