Operating Microscope Aa Om 10

FDA 510(k) K941399 · Appasamy Associates (U.S.A.), Inc.

Substantially Equivalent

510(k) numberK941399

Submission

Device name
Operating Microscope Aa Om 10
Applicant
Appasamy Associates (U.S.A.), Inc.
Millersville, MD, US
Received
March 22, 1994
Decision date
April 22, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FSO – Microscope, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4700
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSO

510(k)DeviceApplicantDecision
K942304MicroflexFSO · Traditional Moeller Microsurgical, Inc.06/13/1994SE
K920689Deemed MSS -- Microscope Support SystemFSO · Traditional Deemed, Inc.11/12/1993SE
K926288Som 6VI (Surgical Operating Microscope)FSO · Traditional Jedmed Instrument Co.10/12/1993SE
K931303Woodlyn Operation MicroscopeFSO · Traditional Woodlyn, Inc.06/25/1993SE
K926513Moller-Wedel Operating MicroscopeFSO · Traditional Moeller Microsurgical, Inc.06/22/1993SE
K910357Som 6VFSO · Traditional Jedmed Instrument Co.02/19/1991SE
K902076J2 MicroscopeFSO · Traditional Jedmed Instrument Co.08/01/1990SE
K874241Opmi MD Surgical MicroscopeFSO · Traditional Carl Zeiss, Inc.12/23/1987SE
K822562Odonto-ScopeFSO · Traditional Treace Medical, Inc.10/06/1982SE
K822181Binocular Oper. Microscopes & AccessorFSO · Traditional Kelleher Corp.08/27/1982SE

Questions and answers

When was Operating Microscope Aa Om 10 cleared by the FDA?

Operating Microscope Aa Om 10 (K941399) received a 510(k) decision of Substantially Equivalent on April 22, 1994, 31 days after the submission was received.

What is the product code of K941399?

The FDA product code is FSO – Microscope, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4700.