Cleared Traditional

K993140 - WATER FOR TISSUE CULTURE, MODELS 1500
(FDA 510(k) Clearance)

K993140 · Conception Technologies · Obstetrics & Gynecology device
Aug 2000
Decision
317d
Days
Class 2
Risk

K993140 is an FDA 510(k) clearance for the WATER FOR TISSUE CULTURE, MODELS 1500. This device is classified as a System, Water, Reproduction, Assisted, And Purification (Class II - Special Controls, product code MTW).

Submitted by Conception Technologies (Irvine, US). The FDA issued a Cleared decision on August 2, 2000, 317 days after receiving the submission on September 20, 1999.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6170.

Submission Details

510(k) Number K993140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date August 02, 2000
Days to Decision 317 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MTW — System, Water, Reproduction, Assisted, And Purification
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.6170