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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formulations, Balanced Salt Solutions
510(k) Number K844877
Device Name HEPES BUFFER IM IN NORMAL SALINE
Applicant
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Applicant Contact JAMES K NOEL
Correspondent
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Correspondent Contact JAMES K NOEL
Regulation Number864.2875
Classification Product Code
KIP  
Date Received12/17/1984
Decision Date 02/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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