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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tenaculum, Uterine
510(k) Number K894891
Device Name IRRIGATOR STAND
Applicant
Commercial Products & Engineering Co.
5001 Kendrick, SE
Grand Rapids,  MI  49512
Applicant Contact JOHN LAMONACO
Correspondent
Commercial Products & Engineering Co.
5001 Kendrick, SE
Grand Rapids,  MI  49512
Correspondent Contact JOHN LAMONACO
Regulation Number884.4530
Classification Product Code
HDC  
Date Received08/01/1989
Decision Date 08/23/1989
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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