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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, hysteroscopic
510(k) Number K872860
Device Name INSUFFLATOR TUBING
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 Number884.1700
Classification Product Code
HIG  
Date Received07/21/1987
Decision Date 11/16/1987
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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