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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K880302
Device Name CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
Applicant
Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact BAUGH, PHD
Correspondent
Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact BAUGH, PHD
Regulation Number864.5425
Classification Product Code
GGN  
Date Received01/25/1988
Decision Date 02/19/1988
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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