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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K861869
Device Name GENTAMICIN-50MG/ML
Applicant
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Applicant Contact NOEL, PH.D.
Correspondent
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Correspondent Contact NOEL, PH.D.
Regulation Number864.2220
Classification Product Code
KIT  
Date Received05/15/1986
Decision Date 05/29/1986
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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