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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 K871928
Device Name CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
Applicant
MEDLINE INDUSTRIES, INC.
99 INVERNESS DRIVE EAST
ENGLEWOOD,  CO  80112
Applicant Contact JO BREHM
Correspondent
MEDLINE INDUSTRIES, INC.
99 INVERNESS DRIVE EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JO BREHM
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/18/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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