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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
8850 M89, BOX 351
RICHLAND,  MI  49083 -0351
Applicant Contact JULIE POWELL
Correspondent
RICHARD-ALLAN MEDICAL
8850 M89, BOX 351
RICHLAND,  MI  49083 -0351
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
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