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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 K051019
Device Name SAFETY NEEDLE
Applicant
Sarstedt, Inc.
1025 St. James Church Rd.
Newton,  NC  28658
Applicant Contact PETER RUMSWINKEL
Correspondent
Sarstedt, Inc.
1025 St. James Church Rd.
Newton,  NC  28658
Correspondent Contact PETER RUMSWINKEL
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/22/2005
Decision Date 07/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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