Cleared Traditional

K965237 - NURSES BOUFFANT CAP
(FDA 510(k) Clearance)

K965237 · Copioumed Intl., Inc. · General Hospital

Aug 1997

Decision

239d

Days

Class 1

Risk

K965237 is an FDA 510(k) clearance for the NURSES BOUFFANT CAP. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).

Submitted by Copioumed Intl., Inc. (Green Valley, US). The FDA issued a Cleared decision on August 27, 1997, 239 days after receiving the submission on December 31, 1996.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K965237 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 31, 1996
Decision Date	August 27, 1997
Days to Decision	239 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement