Cleared Traditional

K971920 - GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
(FDA 510(k) Clearance)

K971920 · Customed, Inc. · General Hospital

Dec 1997

Decision

195d

Days

Class 2

Risk

K971920 is an FDA 510(k) clearance for the GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522), a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on December 4, 1997, 195 days after receiving the submission on May 23, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K971920 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1997
Decision Date	December 04, 1997
Days to Decision	195 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement