Cleared Traditional

K941645 - BIOPSY TRAY
(FDA 510(k) Clearance)

K941645 · Cush Medical Products · General Hospital

Jul 1994

Decision

101d

Days

Class 2

Risk

K941645 is an FDA 510(k) clearance for the BIOPSY TRAY. This device is classified as a Wrap, Sterilization (Class II — Special Controls, product code FRG).

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on July 14, 1994, 101 days after receiving the submission on April 4, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K941645 FDA.gov
FDA Decision	Cleared SEKD
Date Received	April 04, 1994
Decision Date	July 14, 1994
Days to Decision	101 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement