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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
Applicant Contact CARL HAYS
Correspondent
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
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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