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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K893003
Device Name TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE
Applicant
United Medical Systems, Inc.
1901 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact GABREL DEUTSCH
Correspondent
United Medical Systems, Inc.
1901 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact GABREL DEUTSCH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/24/1989
Decision Date 07/14/1989
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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