Cleared Traditional

K897045 - BOWIE-DICK TEST CARD CATALOG NUMBER 008018
(FDA 510(k) Clearance)

K897045 · Edward Weck, Inc. · General Hospital

Feb 1990

Decision

58d

Days

Class 2

Risk

K897045 is an FDA 510(k) clearance for the BOWIE-DICK TEST CARD CATALOG NUMBER 008018. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ).

Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on February 15, 1990, 58 days after receiving the submission on December 19, 1989.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K897045 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1989
Decision Date	February 15, 1990
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—