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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 K942207
Device Name REFLEX INS INSUFFLATION NEEDLE
Applicant
Richard-Allan Medical
8850m89, Box 351
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Richard-Allan Medical
8850m89, Box 351
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/05/1994
Decision Date 05/27/1994
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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