Cleared Traditional

K942807 - SURGICAL LIFT SHEET
(FDA 510(k) Clearance)

K942807 · Surgin Surgical Instrumentation, Inc. · General Hospital

Aug 1994

Decision

49d

Days

Class 1

Risk

K942807 is an FDA 510(k) clearance for the SURGICAL LIFT SHEET. This device is classified as a Lift, Patient, Non-ac-powered (Class I - General Controls, product code FSA).

Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on August 2, 1994, 49 days after receiving the submission on June 14, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5510.

Submission Details

510(k) Number	K942807 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 14, 1994
Decision Date	August 02, 1994
Days to Decision	49 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement