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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K905417
Device Name ELMED PNEUMOMAT DIGITAL
Applicant
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Applicant Contact KARL HAUSNER
Correspondent
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Correspondent Contact KARL HAUSNER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/04/1990
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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