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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K863785
Device Name MAKLER CATHETER
Applicant
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Applicant Contact AMIR PORAT
Correspondent
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Correspondent Contact AMIR PORAT
Regulation Number884.5250
Classification Product Code
HDR  
Date Received09/26/1986
Decision Date 12/11/1986
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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