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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 K852375
Device Name I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
Applicant
Ferris Mfg. Corp.
16 W 300 83rd St.
Burr Ridge,  IL  60527 -5848
Applicant Contact CARL HAYS
Correspondent
Ferris Mfg. Corp.
16 W 300 83rd St.
Burr Ridge,  IL  60527 -5848
Correspondent Contact CARL HAYS
Regulation Number880.5200
Classification Product Code
LRS  
Date Received06/04/1985
Decision Date 07/11/1985
Decision Substantially Equivalent - With Drug (SESD)
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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