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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K994361
Device Name ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
Applicant
Genesis Industries, Inc.
303 S. Mckay Ave.
P.O. Box 39
Spring Valley,  WI  54767
Applicant Contact ANGELA RICHARDSON
Correspondent
Genesis Industries, Inc.
303 S. Mckay Ave.
P.O. Box 39
Spring Valley,  WI  54767
Correspondent Contact ANGELA RICHARDSON
Regulation Number884.6160
Classification Product Code
MQK  
Date Received12/27/1999
Decision Date 02/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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