510(k) K896008

Device: MODEL 6500 MERCURY ARC LIGHT SOURCE
Applicant: MEDICAL DYNAMICS, INC.
510(k) number: K896008
Product code: GCP
Decision: Substantially Equivalent (SESE)
Decision date: 1989-12-27
Date received: 1989-10-13
Regulation: 876.1500
Classification name: Endoscope, Ac-powered And Accessories
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: JO BREHM
Address: 99 Inverness Dr. E. Englewood CO US 80112 80112

FDA Registration Numbers#

3009217531
3007388124
3004784537
9610773
8010487
3011986317
3013247477
8043235
1000343527
3011416394
3012460907
3007960282
3006680097
9614969
3013031133
8010257

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCP #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K954614	EOS BRAND DISPOSABLE PROCTOSCOPE	North Eos Industries, Inc.	1996-04-10
K896505	PORGES UNIVERSAL HANDLES	Porges Corp.	1990-01-30
K862424	STEERABLE CATHETER SYSTEM	Endovations	1986-09-22
K860103	MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE	Endotherapeutics	1986-02-12
K843683	MODULAR FIBERSCOPE SYSTEM	Reichert Scientific Instruments	1985-01-18
K833859	TAMPONADE BALLOON CUFF	American Endoscopy, Inc.	1984-01-03
K821999	ENDOSCOPIC SCLEROTHERAPY BALLOON	Retech	1982-08-27
K801247	CCD ENDOSCOPE AND ATTACHMENTS	Welch Allyn, Inc.	1980-07-28
K790071	ENDOSCOPE AND ACCESSORIES	Olympus Corp.	1979-04-02
K771918	FIBEO OPTICS ILLUM. SYSTEM	Propper Mfg. Co., Inc.	1977-10-20
K771919	FIBER OPTICS SIGMOIDOSCOPE	Propper Mfg. Co., Inc.	1977-10-20
K771920	FIBER OPTICS PROCTOSCOPE	Propper Mfg. Co., Inc.	1977-10-20

Legacy Summary#

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