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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K914475
Device Name IV START KIT
Applicant
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Applicant Contact VARUN SONI
Correspondent
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Correspondent Contact VARUN SONI
Regulation Number880.5200
Classification Product Code
LRS  
Date Received10/08/1991
Decision Date 03/18/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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