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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 K900988
Device Name AMCATH SUCTION-IRRIGATION TUBE
Applicant
Intl. Medical, Inc.
175 Connecticut Mills Ave.
Danielson,  CT  06239
Applicant Contact H WETTERMANN
Correspondent
Intl. Medical, Inc.
175 Connecticut Mills Ave.
Danielson,  CT  06239
Correspondent Contact H WETTERMANN
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/02/1990
Decision Date 05/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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