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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K032526
Device Name BINDER CO2 INCUBATOR SERIE CB
Applicant
Binder GmbH
Bergstrasse 14
Tuttlingen,  DE D-78532
Applicant Contact PAUL DISTLER
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact PAMELA GWYNN
Regulation Number884.6120
Classification Product Code
MQG  
Date Received08/15/2003
Decision Date 08/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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