510(k) K974563

Device: COLPO CUP CVC-2000
Applicant: CLINICAL INNOVATIONS, INC.
510(k) number: K974563
Product code: HDP
Decision: Substantially Equivalent (SESE)
Decision date: 1998-03-02
Date received: 1997-12-05
Regulation: 884.4530
Classification name: Elevator, Uterine
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: WM. DEAN WALLACE
Address: 6477 S. Cottonwood St. Murray UT US 84107 84107

FDA Registration Numbers#

8022078
9611102
3006554912
1418479

Source Documents#

Other 510(k) Records For Product Code HDP #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K974801	SINGLE CHANNEL BALLOON CANNULA	Conkin Surgical Instruments , Ltd.	1998-07-09
K882054	HYSTERO KIT	Zinnanti Surgical Instruments, Inc.	1988-09-29
K820672	HASSON BUEC-3	Bivona Medical Technologies	1982-07-30

Legacy Summary#

summary

FDA Review#

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