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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K931879
Device Name REFLEX HTR
Applicant
RICHARD-ALLAN MEDICAL IND., INC.
8850 M89
BOX 351
RICHLAND,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
RICHARD-ALLAN MEDICAL IND., INC.
8850 M89
BOX 351
RICHLAND,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/14/1993
Decision Date 03/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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