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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Umbilical
510(k) Number K860445
Device Name CLAMP-N-CUT
Applicant
Mmi, Inc.
19500 W. Eight Mile Rd.
P.O. Box 305
Southfield,  MI  48037
Applicant Contact MATTLER
Correspondent
Mmi, Inc.
19500 W. Eight Mile Rd.
P.O. Box 305
Southfield,  MI  48037
Correspondent Contact MATTLER
Regulation Number884.4530
Classification Product Code
HFW  
Date Received02/04/1986
Decision Date 04/04/1986
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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