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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K910209
Device Name LAPAROSCOPIC IRRIGATOR/ASPIRATOR
Applicant
SOLOS MFG.
820 SWAN DR.
MUKWONAGO,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
SOLOS MFG.
820 SWAN DR.
MUKWONAGO,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/15/1991
Decision Date 04/29/1991
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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