Cleared Traditional

K885019 - BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
(FDA 510(k) Clearance)

K885019 · Bemis Health Care · General Hospital

Jan 1989

Decision

57d

Days

Class 2

Risk

K885019 is an FDA 510(k) clearance for the BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI., a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Bemis Health Care (Sheboygan Falls, US). The FDA issued a Cleared decision on January 25, 1989, 57 days after receiving the submission on November 29, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K885019 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 1988
Decision Date	January 25, 1989
Days to Decision	57 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—