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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K890109
Device Name SAFEPETTE DISPENSER
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 Number862.1675
Classification Product Code
JKA  
Date Received01/10/1989
Decision Date 02/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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