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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Administration, Intravascular
510(k) Number K852254
Device Name I.V. STAT MASTER
Applicant
The Master Medical Corp.
135 S. La Salle St.
Chicago,  IL  60603
Applicant Contact SHERYL'A, MARCOUILLE
Correspondent
The Master Medical Corp.
135 S. La Salle St.
Chicago,  IL  60603
Correspondent Contact SHERYL'A, MARCOUILLE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/24/1985
Decision Date 11/18/1985
Decision Substantially Equivalent (SESE)
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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