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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K852167
Device Name ISOVOL-EXCHANGE TRAY
Applicant
Rocky Mountain Medical Corp.
5680 S. Syracuse Cir.
P.O. Box 4783
Greenwood Village,  CO  80111
Applicant Contact RICHARD J ROSENBAUM
Correspondent
Rocky Mountain Medical Corp.
5680 S. Syracuse Cir.
P.O. Box 4783
Greenwood Village,  CO  80111
Correspondent Contact RICHARD J ROSENBAUM
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received05/20/1985
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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