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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 K845021
Device Name MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
Applicant
Medline Industries, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Applicant Contact JO BREHM
Correspondent
Medline Industries, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Correspondent Contact JO BREHM
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/27/1984
Decision Date 05/20/1985
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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