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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 K812200
Device Name INSUFFLATOR
Applicant
REZNIK INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
REZNIK INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/04/1981
Decision Date 09/29/1981
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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