510(k) K011598

Device: WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
Applicant: IRVINE SCIENTIFIC SALES CO., INC.
510(k) number: K011598
Product code: MTW
Decision: Substantially Equivalent (SESE)
Decision date: 2001-06-13
Date received: 2001-05-24
Regulation: 884.6170
Classification name: System, Water, Reproduction, Assisted, And Purification
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: WENDELL LEE
Address: 2511 Daimler St. Santa Ana CA US 92705 92705

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00857515006078	Water for Assisted Reproductive Technologies (A.R.T.) Use	FUJIFILM IRVINE SCIENTIFIC, INC.	2016-09-10
00893727002880	Water for Assisted Reproductive Technologies (A.R.T.) Use	FUJIFILM IRVINE SCIENTIFIC, INC.	2016-09-10

Other 510(k) Records For Product Code MTW #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K993140	WATER FOR TISSUE CULTURE, MODELS 1500	Conception Technologies	2000-08-02

Legacy Summary#

summary

FDA Review#

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