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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pipette, Pasteur
510(k) Number K896670
Device Name TIP TOP(R) DISPENSER CAPS
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.6160
Classification Product Code
GJW  
Date Received11/27/1989
Decision Date 03/23/1990
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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