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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K884623
Device Name SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
Applicant
Safe-Tec Clinical Products, Inc.
Northampton Industrial Park
163 Railroad Dr.
Ivyland,  PA  18974
Applicant Contact G KENDRICK
Correspondent
Safe-Tec Clinical Products, Inc.
Northampton Industrial Park
163 Railroad Dr.
Ivyland,  PA  18974
Correspondent Contact G KENDRICK
Regulation Number864.6150
Classification Product Code
GIO  
Date Received11/04/1988
Decision Date 12/01/1988
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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