Cleared Traditional

SELF-CONTAINED MOBILE OPHTHAL. OPER. .

K822427 · Surgi-Quip Inc.U · General & Plastic Surgery

Sep 1982

Decision

33d

Days

Class 1

Risk

About This 510(k) Submission

K822427 is an FDA 510(k) clearance for the SELF-CONTAINED MOBILE OPHTHAL. OPER. ., a Table, Operating-room, Manual (Class I — General Controls, product code FSE), submitted by Surgi-Quip Inc.U (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 33 days after receiving the submission on August 12, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K822427 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1982
Decision Date	September 14, 1982
Days to Decision	33 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—