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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge, Hematocrit
510(k) Number K913128
Device Name HEMATASTAT C-70B
Applicant
Separation Technology, Inc.
2340 S. 2700 W.
Salt Lake City,  UT  84119
Applicant Contact DALE ZABRISKIE
Correspondent
Separation Technology, Inc.
2340 S. 2700 W.
Salt Lake City,  UT  84119
Correspondent Contact DALE ZABRISKIE
Regulation Number864.6400
Classification Product Code
GKG  
Date Received05/10/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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