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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 K772297
Device Name INSUFFLATOR, MODEL G100 & 200
Applicant
KLI
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KLI
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/13/1977
Decision Date 01/05/1978
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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