Cleared Traditional

K934731 - MEDSURG STERILE IMAGING PRODUCTS
(FDA 510(k) Clearance)

K934731 · Medsurg Industries, Inc. · General Hospital

Mar 1994

Decision

180d

Days

Class 1

Risk

K934731 is an FDA 510(k) clearance for the MEDSURG STERILE IMAGING PRODUCTS. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on March 28, 1994, 180 days after receiving the submission on September 29, 1993.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.

Submission Details

510(k) Number	K934731 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 1993
Decision Date	March 28, 1994
Days to Decision	180 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement