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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 K936155
Device Name ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA
Applicant
Micromedical Devices, Inc.
317 Paragon Way
Castle Pines Village,  CO  80104
Applicant Contact EDWIN L ADAIR
Correspondent
Micromedical Devices, Inc.
317 Paragon Way
Castle Pines Village,  CO  80104
Correspondent Contact EDWIN L ADAIR
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/27/1993
Decision Date 04/11/1994
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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