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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K900857
Device Name NON STERILE PARENTERAL SUPPLY KIT
Applicant
Intermed, Inc.
15 White Lake Rd.
Sparta,  NJ  07871
Applicant Contact NORM RUEDT
Correspondent
Intermed, Inc.
15 White Lake Rd.
Sparta,  NJ  07871
Correspondent Contact NORM RUEDT
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/23/1990
Decision Date 05/22/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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