Model 902 Stand

FDA 510(k) K780759 · Applied Medical Research

Substantially Equivalent

510(k) numberK780759

Submission

Device name
Model 902 Stand
Applicant
Applied Medical Research
Mchenry, IL, US
Received
May 8, 1978
Decision date
May 19, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FSH – Tray, Surgical, Needle
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSH

510(k)DeviceApplicantDecision
K884876S 4 Instrument StandFSH · Traditional Carl Zeiss, Inc.12/15/1988SE
K883578S 21 Instrument StandFSH · Traditional Carl Zeiss, Inc.09/13/1988SE
K821921Stand, Surg. Instrument & DressingFSH · Traditional Emerson-Sack-Warner Corp.07/30/1982SE
K813338Biopsy Needles & TraysFSH · Traditional American Pharmaseal Div. Ahsc01/28/1982SE
K813337Skinny Chiba Needle & TrayFSH · Traditional American Pharmaseal Div. Ahsc01/28/1982SE
K813335Percutaneous Transhepatic Cholang. TrayFSH · Traditional American Pharmaseal Div. Ahsc01/08/1982SE
K772188FSH Ria Kit (125I)FSH · Traditional Diagnostic Products Corp.12/22/1977SE

More from Diagnostic Products Corp.

510(k)DeviceDecision
K800025Dinamap Research Monitor 1245DXN · Traditional 02/01/1980SE
K791580Cerebral Function Monitor 870OMA · Traditional 09/04/1979SE
K791159Dinamap Model 855DXN · Traditional 07/30/1979SE
K790322Optional Accessory Foot Switch Model 100EBW · Traditional 05/14/1979SE
K790328Model 1051, MonitorDXN · Traditional 03/02/1979SE
K782073Dinamap Models 1160 and 1165DSK · Traditional 02/23/1979SE
K781064Dinamap Model 848DSK · Traditional 09/07/1978SE
K781053Dinamap Model 846DSK · Traditional 09/07/1978SE
K781311Electrode, Needle, CFMGXZ · Traditional 08/21/1978SE
K780754Neonatal MonitorDXN · Traditional 06/14/1978SE

Questions and answers

When was Model 902 Stand cleared by the FDA?

Model 902 Stand (K780759) received a 510(k) decision of Substantially Equivalent on May 19, 1978, 11 days after the submission was received.

What is the product code of K780759?

The FDA product code is FSH – Tray, Surgical, Needle, a Class I (low risk) device regulated under 21 CFR 878.4800.