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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 K900808
Device Name RAPID AUTOMATIC PNEUMOPERITONEUM-I
Applicant
TREK MEDICAL PRODUCTS, INC.
820 SWAN DR.
P.O. BOX B
MUKWONAGO,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
TREK MEDICAL PRODUCTS, INC.
820 SWAN DR.
P.O. BOX B
MUKWONAGO,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number884.1730
Classification Product Code
HIF  
Date Received02/21/1990
Decision Date 09/19/1990
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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