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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 K963428
Device Name UMBILICAL CLAMP AND CUTTER
Applicant
R.O.S.T. Medical Development, Inc.
11800 28th St., N.
St. Petersburg,  FL  33716
Applicant Contact HOWARD K MANN
Correspondent
R.O.S.T. Medical Development, Inc.
11800 28th St., N.
St. Petersburg,  FL  33716
Correspondent Contact HOWARD K MANN
Regulation Number884.4530
Classification Product Code
HFW  
Date Received08/30/1996
Decision Date 04/01/1997
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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